FDA 3632 Laser (esubmitter)

3632 Laser Product rpt (OMB 0910-0025)
Section: eRadHealth Menu
Introduction

Electronic Product Radiation Safety Reporting
Form
This software application is intended to automate the hard copy product reporting forms in the effort of the Center for Devices and
Radiological Health (CDRH) to become capable of accepting electronic submissions from industry and to improve our review
process. This FDA Electronic Submission (eSub) software is the next version of the application developed to allow us to accept all
Radiological Health reports and other submissions electronically and improve the ability of CDRH to accomplish its mandated
product and industry evaluations in a timely and efficient manner.
All electronic reports and correspondence can either be transferred to CD and mailed to the address below, or can be sent via the
FDA Electronic Submissions Gateway to CDRH. If you follow instructions to set up an account with the FDA Gateway, it currently
may take several weeks,, but when you submit through it you will receive your acknowledgement email message with Accession
Number within minutes! Or, in the interest of faster turn-around for a one-time urgent report of if you submit few reports, you may
simply fill out this template creating the submission and then at 'Packaging' follow the instructions to transfer the files to a CD to
mail in. This method of submitting your report will be acknowledged by an email with the Accession Number within several days.
Information about the FDA Electronic Submissions Gateway can be found at
www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Please contact the Gateway Helpdesk with your
questions about that system.
Electronic submissions on CD should be mailed directly to the Document Control Center at:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Submissions received in the mail on CD will be processed within a few days of receipt.
Note about eSubmitter software:
Instructions provided in this software briefly summarize the requirements of the regulations under the Federal Food, Drug and
Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of
electronic products that emit radiation. The software provides questions relevant to requirements in the performance standards and
may include explanations or clarification about the performance, labeling, and informational requirements of the standard. It does
not replace the regulations, however, and if there is any conflict between the software and the regulations, the regulations must
prevail. Throughout this application, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in
parentheses. Please consult them before making design or procedural decisions.
Regulatory requirements for radiological products can be found at http://www.fda.gov/Radiation-EmittingProducts/default.htm
and for medical devices are located at www.fda.gov/M/devaDvices/default.htm. If you have specific questions about the
regulations, please contact us at: [email protected].
If you have specific questions regarding this software, please contact the eSub team by email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your comments and suggestions to the eSub
team as often as you like.
Thank you for your continued support of the FDA Electronic Submission Program (eSub).

Definitions
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3632 Laser Product rpt (OMB 0910-0025)

Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing, assembling,
or importing of electronic products (21 CFR1000.3(n)). Manufacturers of electronic products subject
to 21CFR1000-1050 must:

• Design and manufacture their products to be in
compliance with applicable performance standards;
• Test their products to assure compliance;
• Certify compliance of their products;
• Maintain test and distribution records and a file of
correspondence concerning radiation safety, safety
complaints, and inquiries;
• Use the published reporting forms or electronic
software application to submit reports to CDRH,
including Product reports describing the manner of
compliance of the product design and testing
program and Annual Reports summarizing their
compliance testing;
• Report accidental radiation occurrences (i.e.,
possible, suspected,or known exposures);
• Report any radiation defects or noncompliances;
and
• Recall (i.e., repair, replace, or refund the purchase
price of) defective or noncompliant products.
Importers

Importer is any person of organization engaged in the business of importing electronic products. An
importer is considered to be a manufacturer. The requirements for Manufacturers given above also
apply to importers if the requirements have not been done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
Every manufacturer of electronic products, prior to offering such product for importation into the
United States, shall designate a permanent resident of the United States as the manufacturer`s
agent upon whom service of all processes, notices, orders, decisions, and requirements may be
made for and on behalf of the manufacturer as provided in section 536(d) of the Radiation Control
for Health and Safety Act of 1968 (21U.S.C. 360mm(d)) and this section. The agent maybe an
individual, a firm, or a domestic corporation. For purposes of this section, any number of
manufacturers may designate the same agent.

From The Federal Food, Drug, and Cosmetic ActSec 536 [21 U.S.C. 360mm](d)
Designation of agent for purposes of service
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3632 Laser Product rpt (OMB 0910-0025)
It shall be the duty of every manufacturer offering an electronic product for importation into the
United States to designate in writing an agent upon whom service of all administrative and judicial
processes, notices, orders, decisions, and requirements may be made for and on behalf of said
manufacturer, and to file such designation with the Secretary, which designation may from time to
time be changed by like writing, similarly filed. Service of all administrative and judicial processes,
notices, orders, decisions, and requirements may be made upon said manufacturer by service upon
such designated agent at his office or usual place of residence with like effect as if made personally
upon said manufacturer, and in default of such designation of such agent, service of process,
notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial
proceeding for enforcement of this part or any standards prescribed pursuant to this part may be
made by posting such process, notice, order, requirement, or decision in the Office of the Secretary
or in a place designated by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an
electronic circuit in such product.
Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or acts as part of an electronic circuit and (ii)
emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in
clause (A) and which when in operation emits (or in the absence of effect

Role
What is your role?

[L]

Note:

If you are acting as an agent of the actual manufacturer, please select your role as, for example,
perhaps an Importer or Consultant. Later in the report, under Manufacturer Data, you will be
prompted to enter both manufacturer and submitter information.

Information:

The following screen provides several options for you to accurately define what type of eSubmission
you intend to create for FDA. Below are explanations of your options. Please feel free to review this
screen, advance to the next screen and view the picklists, but if you're confused, come back to read
this screen again to be certain you are selecting the correct report or correspondence type you want
to create.

Submission Information
Use the radio buttons to identify the type of submission you are preparing. (Supplements should be prepared using the
same document type as the original submission.) [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Submission is this?
(Supplements should be submitted
selecting the same document type
as the original report.)

(
(
(
(
(

)
)
)
)
)

Radiation Safety Report (Product) Report (21 CFR 1002.10)
Annual Report (21 CFR 1002.13)
Laser Light Show Documents (all relevant documents) (21 CFR 1040.11(c))
Correspondence
Variance Request (General, not Laser Light Show) (21 CFR 1010.4)

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3632 Laser Product rpt (OMB 0910-0025)
( ) Laser Original Equipment/Component Manufacturer Registration (21 CFR
1040.10(a)(3)(ii))
( ) Abbreviated Report (21 CFR 1002.12)
After answering the Submission Type question above, one of the questions below may become active and required (see
the blue dot to the right of the question). If there is an active question, select the appropriate product area or document
type from the question's pick list. [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Product is this Radiation Safety Report about?
[L]
What Type of Product is this Annual Report about?
[L]
What Laser Light Show Document are you filing?
[L]
What Type of Correspondence is this?
[L]
What Type of Product is this Variance Request about?
[L]

FDA or State Inspector
Abbreviated Report Applicability
OEM Laser Applicability

Section: Manufacturer Data
General Information

General Information for Radiological Health
Products
Manufacturers of products subject to performance standards under the Federal Food, Drug, and Cosmetic Act (FFDCA), Chapter V,
Subchapter C - Electronic Product Radiation Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product and Annual reports. This application will
assist manufacturers of electronic products that emit radiation in providing adequate reporting of radiation safety testing and
compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify
Reporting and Notification requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate form (21 CFR 1002.7). This software
application serves the same report responsibility, so long as the submitter or manufacturer prints out the cover letter and sends it in
along with the CD containing the report files. The submitter of the report will receive an acknowledgment letter (or email message)
with the accession number that CDRH assigns to the report. Please reference this accession number in the future when providing
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3632 Laser Product rpt (OMB 0910-0025)
additional information about this model family in either a supplement or the annual report. If a report is incomplete or inadequate
CDRH may reject it and return it for completion. CDRH will not enter a rejected report into our database.

CDRH DOES NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is
the manufacturer's responsibility to certify that their products comply with all applicable standards
(21 CFR 1010 - 1050), based on a testing program in accordance with good manufacturing
practices. Prior to the shipment of products in interstate commerce, 21 CFR 1002 requires the
manufacturer to submit the product and Annual Reports and to comply with all applicable
importation requirements (21CFR 1005). If there are deficiencies, CDRH may disapprove the firm's
quality control and testing program, determine that the product contains a radiation defect, or
determine that the product fails to comply with a standard. CDRH will notify the manufacturer if we
make such a determination. CDRH may require the manufacturer to cease introduction into U.S.
commerce until deficiencies are corrected, and to initiate a corrective action program (21CFR 1003 1004) for products already introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all attachments are PDF files only, and the cover
letter is printed out and included with a real signature. Translate any text that appears in a language other than English into English
in a complete and accurate manner. Keep a copy (save a copy to your hard drive) of the completed report in your records.
Regulatory information is available on the Internet under www.fda.gov/Radiation-EmittingProducts/default.htm. No copyright
exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms, website, or future electronic submissions,
you may direct the comments to [email protected].
A complete Product Report is required for each product model or model family. Product Reports are now more generally referred to
as Radiation Safety Reports to distinguish the Radiological Health submissions from medical device submissions. CDRH suggests
that a complete report on one model of a family be submitted, with a separate Supplemental Report for each of the other models in
the family. The Supplemental Report should respond in detail to the parts of the form where there are differences to report,
referencing the number of the affected item. Items that are unchanged will still appear in the supplement from the original report.
When new models of a product are introduced, if the models satisfy the criteria for an established reporting exemption or if the new
models do not involve changes in radiation emission or performance requirements, then the manufacturer need not report the models
prior to introduction into commerce. Rather, the manufacturer is only required to identify them in the annual report, or in quarterly
updates to the annual report. Quarterly updates to annual reports may be submitted using the Annual Report software included in
this application. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and consistently used. Please use the terms as defined
in Section 1040.10(b) and in the IEEE Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).

Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing, and reviewing the
collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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3632 Laser Product rpt (OMB 0910-0025)
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number."

Manufacturer and Report Information
Confirmation:

This Manufacturer section of this report requests names, addresses, phone numbers, etc. for your
firm, various officials of your firm, consultants who may assist in preparing the report, parent firm (if
any), importer and designated agent (for foreign firms). Some of this information is mandatory and its
absence will prevent you from completing the report submission. Because some of these entries may
be redundant, utilize the 'Contact Address Book' feature so you can save your data and reselect the
entries later and in the future. (See the upload/download buttons in upper right corner of the
screens).
You can check for missing data at any time using the "Missing Data Report" from the "Output" menu
across the top of this application. The Missing Data Report lists all missing responses that are
required (that have the blue dot).

Information:

Attention: Variance Applicants
If you are acting as an agent or consultant for, or on behalf of, or filing for, a company that will be
manufacturing or producing a Class IIIb or IV projector or laser light show or both which require an
approved variance, the following explanations may provide further clarification.
Manufacturer: This is the firm or company who is requesting the variance, will certify the product or
show, and will be the holder and owner of the variance. This is not the agent or consultant who may
be filing this report or Variance request for the manufacturer; that agent may be the submitter,
identified in a later screen.
Responsible Individual: This person works for the Manufacturer and is responsible for compliance of
the projector and/or show. In the case of laser light shows, he or she may be the company president,
CEO, or the laser light show head operator or a manager who oversees the shows.
Reporting Official: This person works for the Manufacturer and is responsible for reports,
recordkeeping, and submitting FDA required documents and correspondence.

Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the performance
standard. This firm develops and maintains the quality control and testing program that is the basis
for the certification of this product. Additionally, this firm usually is the owner of the product design
and manufacturing process design.
Be sure to enter address information for each tab below:

Select the Manufacturer's address from the Establishment Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: ESTABLISHMENT COMPLEX]

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with this
establishment.

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3632 Laser Product rpt (OMB 0910-0025)
Select the Responsible Individual from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
CONTACT COMPLEX]

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing
all aspects of the testing and quality control procedures for certification as reported to FDA in the
product report. Documentation of changes intesting and quality control procedures submitted to FDA
must be signed by this individual.

Select the Reporting Official from Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Report Submitter
Note:

The submitter may be a consulting individual or firm providing assistance in report preparation and
maintenance. Documents or submissions such as this one that are prepared by the submitter must
have an accompanying authorization letter from the manufacturer's reporting official for authenticity.

Select the Submitter from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

[L]

Select the Parent Establishment and Contact from the Contact Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: CONTACT COMPLEX]

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

[L]

Written Agreement
Item: 1 (could contain up to 10 items with none required)
Note:

The manufacturer who is certifying the product being reported is the manufacturer of record. If this
firm is not in the United States, please identify your current Importer(s).

Note:

If any of the required responses below do not apply to your designated agent, enter 'NOT
APPLICABLE' or 'NA.'

Select the Designated Agent from the Contact Address book:
Contact Name
Occupation Title
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3632 Laser Product rpt (OMB 0910-0025)
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
Attach a copy of written agreement with the designated U.S. agent:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Importer
Item: 1 (could contain up to 10 items with none required)
Select the Importer from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Additional Manufacturing Locations
Item: 1 (could contain up to 100 items with none required)
Note:

If any of the products certified in this report are manufactured at locations other than listed in the
Manufacturer Responsiblefor Product Compliance section, then the names, addresses, and FDA
registration numbers should be provided. In addition any codes used on labels to identify a
manufacturing location must be provided. Each factory location must assure all production
procedures are followed identically step by step as provided in this report.If the procedures are not the
same then separate reports should be filed.

Select the Manufacturer Address from the Establishment Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
ESTABLISHMENT COMPLEX]
Code used on identification labels:

Section: Product Data
Product and Model Identification

Attention - Information about this section
In this section you'll be asked to identify several required or optional things which will help
FDA/CDRH staff to prioritize their reviews. You'll be asked to consider the following aspects:
(1) Identify your product's radiation type and the CDRH Product Code.
(2) Enter an Accession number if this will be a report supplment. If you are preparing a supplement, you'll see that after entering a
valid 7-digit Accession number many questions will no longer be required (they will either be disabled or will be optional, meaning
they will no longer have the blue dot).
(3) You will also have several questions that are of high significance for FDA/CDRH - why you might be submitting this report or
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3632 Laser Product rpt (OMB 0910-0025)
correspondence. Please read these questions carefully, referring to the 21 CFR regulations on the website www.FDA.gov if you are
unsure if the question is relevant to your firm's situation.
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't seem to fit under other questions,
we have a final "Additional Information" question in this section which invites you to add comments and/or attach a file that
provides further information from your firm about this submission. This is the place to add that extra information.

Product Type Reported
Note:

Each product that CDRH regulates is assigned a product code by CDRH.

What is the product code?
To select the three letter product code,
- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes from which to
choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code. [QUESTION TYPE NOT YET
IMPLEMENTED: RH SINGLE PRODUCT CODE]
If Other, provide a category name for this specific product.

Examples of Laser Products
Product Type:

Product Examples:

Medical Laser Products:

Ophthalmic, Dermatological, Laser Hair
Removal, Cardiovascular, Angioplasty,
Photodynamic Therapy Laser with fiber Optics,
ENT, Ob/Gyn, Urology, Laser for Pain Therapy,
Laser for Wound Healing, Dental Lasers

In Vitro and Other Medical Laser Products:

Veterinary Laser, Automated Blood Cell
Separator, Automated Differential Cell Counter,
Cell Sorters

Positioning Medical Laser Products:

X-Ray Field Indicator Laser Light, Patient
Positioning Monitor

Laser Light Show/Display Products:

Low and High-Power Laser Light Show
Projectors, Laser Light Shows,Laser Video
Projectors

Other Demonstration Laser Products

Laser Science Education Products

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3632 Laser Product rpt (OMB 0910-0025)

Surveying, Leveling, Alignment Laser Products:

Ranging (Geodimeter) Laser Products,
Alignment Laser Product, Laser Pointers, Laser
Target Designator, Laser Aiming Products

Safety, Security, Surveillance Laser Products:

IR Laser Night Vision Illuminator System,
Collision-Avoidance Laser System, Laser
Automotive Lighting & Signals, IR Laser Intrusion
Detection/Security System, Laser Radar (Lidar)
or Speed Measurement, Laser Weapon (Military
or Police)

Toy, Novelty, Play Laser Products:

Laser Toys, Pet Laser Toys, Laser Tag, Laser
Play Guns

Laser Spectroscopy Instrument, Particle-Size
Research, Scientific, Laboratory Laser Products: Measuring Instrument, Analytical Measuring and
Detection Laser Product

Material Processing Laser Products:

Laser Cutters, Laser Welders, Microelectronic
Mask or Chip Checking/Repair, UV Curing, Laser
Print Industry Plate Maker, Laser Process
Control, Laser Vision System

Data Measurement, Transmit, Control Laser
Products:

Fiber Optic Communication and Data Transfer
Laser System, IR Free-Space Data
Transmit/Control Laser, Laser Remote Controller

Utility/Peripheral Laser Products:

Laser Reprographics, Laser Printer, FAX
Machine, CD, CD-ROM, DVD, DVD-ROM
Players, CD-R, CD-RW, DVD-R, DVD+R, DVDRAM, DVD+RW, DVD-RW Recorder, UPC
Reader (Bar Code Reader)

Other Laser Products:

Laser Automotive or Transport Vehicle
Accessory, General Purpose Laser Products

Information:

LASER RADIATION CLASSES AND MEDICAL DEVICE CLASSES
The FDA regulates many products, in particular laser products and medical devices of all kinds. In
the Federal laser product performance standard, lasers are classified I through IV based on maximum
accessible radiation levels during operation. Meanwhile, devices are classified I through III based on
device complexity and degree of control the FDA will have on the device manufacturing and
clearance. Unfortunately, the dual usage of 'classification' (with two different and unrelated meanings)
is a huge point of confusion for laser product manufacturers, both medical and non-medical. When
searching for your laser product in the Product Code database, you will see numerous laser devices

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3632 Laser Product rpt (OMB 0910-0025)
and their device classes, as well as non-medical lasers identified as unclassified (as a device).
Elsewhere in the software you will select which laser (radiation) class you are reporting on. So, if you
are reporting on non-medical products, please disregard the (device) Class column.

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the Product Type [L]
Reported section?
Since this is not the first time you've reported on this type of product, then is this a report supplement to a
previously reported model family?

[L]

Provide the Accession Number of the original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here, such as
PMAs, 510(k)s, IDEs, etc. See Accession number description below.)

Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

[L]

If you are requesting a renewal, extension, or amendment, please provide the variance number that was
issued by CDRH.
Stop:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance
Request separate from this report. To do this, open a new report (File > New) and select either
"Laser Light Show Variance Request" or "Variance Request (General, not Laser Light Show)" as your
Type of Submission in the Submission Information Screen. If you select "Variance Request (General,
not Laser Light Show)r" you must select the product for which you are requesting a variance with the
pick list in the bottom section of the screen.

Special Considerations
Note:

Check all items in this section that may apply to this submission.

Information:

If this product will require a formally approved Variance from a certain performance requirement, you
will need to complete two Reports for FDA, both (1) this Radiation Safety Report (RSR) on this
product, and (2) a Variance Request report. This eSubmitter software application package includes a
general Variance Request form as well as the specific Laser Light Show Variance Request form.
Both the Product RSR file and the appropriate Variance Request Correspondence file must be
submitted to CDRH following the regular files packaging procedures in this application. Both may be
transferred to the same CD or submitted via the FDA ESG to submit to the FDA/CDRH.
In addition, any Variance Request form must be printed out and the signed hard-copy sent to FDA's
Division of Dockets Management at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
NOTE: There is no need to send a copy of the CD to Division of Dockets Management.

Noncompliances or Defects
Does this document or any of its attachments contain:
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3632 Laser Product rpt (OMB 0910-0025)
A notification of noncompliance or defect?

[L]

You may provide an explanation and/or attach a document here:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Responses to Noncompliances or Defects
Does this document or any of its attachments contain any of these responses concerning noncompliances or defects?
A refutation of noncompliances or defects identified to your firm?

[L]

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

[L]

Corrective action plans you intend to implement to correct noncompliances or defects discovered in past or
current production?

[L]

Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information on
design changes for future production, the design change information must be submitted in a Radiation
Safety (Product) Report or supplemental report. Both the proposed CAP and the design changes
may be submitted in one document if you prepare a product report and choose to include the CAP in
it as a file attachment. Alternatively, you may create a separate eSubmission for the CAP using the
"Correspondence" type template and selecting "Follow-up correspondence to FDA."

A description of any design changes that correct noncompliances for future production?
Note:

[L]

If you are submitting information on product design changes for future production due to a discovery
of noncompliances or defects in current production, you must use the Radiation Safety (Product)
Report template to create the report . Correspondence templates may be used to submit other
information such as a proposed corrective action plan pertaining to a noncompliance or defect.

You may add an explanation and/or attach a document here:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (21 CFR 1010.5)?

[L]

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

[L]

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

[L]

Request for approval of alternate labeling?

[L]

Application for alternate test procedures (21 CFR 1010.13)?

[L]

You may provide an explanation and/or attach any relevant documents here:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Variance Requests
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3632 Laser Product rpt (OMB 0910-0025)
Information:

Please note: in addition to responding to these questions below, a separate General Variance
Request or Laser Light Show Variance Request form must be completed and submitted to CDRH,
with a hard copy sent to FDA's Division of Dockets Management as instructed below for any variance
request. The information requested on this screen does not constitute the full structured content of
the variance request. The 2 types of Variance forms can be created in eSubmitter by selecting the
appropriate Variance submission type under the eRad Health Menu section of this application.

Message:

Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.
Item 1
Item 2
Item 3
Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details

[HTML Text]

File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv,
.zip)]

Stop:

For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission instructions
located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual. If sending
a CD & submittal letter, please mail to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Additionally, a paper version (hard-copy) of the signed Variance request document should be
submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an FDA inspection?

[L]

What was the date of the inspection?

[Date]

A response to a Warning letter or a Notification of Noncompliance or Defect from the FDA?

[L]

What was the date of the Warning Letter or other notification letter?

[Date]

A response to a report review inquiry from the CDRH (the inquiry may have been in the form of a letter,
email, or phone call)?

[L]

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3632 Laser Product rpt (OMB 0910-0025)
What was the date of the inquiry?

[Date]

A response to any other communication from FDA?

[L]

What was the date of the communication?

[Date]

Provide an explanation:
[Multi-Line Plain Text]

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!
Is there any other relevant information or additional comments that would help expedite the review of this submission?
Click the plus sign below to attach any supporting files.
File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv,
.zip)]

Details

[HTML Text]

Private Labeling
Is the product sold by other companies under different brand names?

[L]

Private Labeling-Table
Item: 1 (could contain up to 20 items with 1 required)
Give the name and address of the manufacturer:
Establishment Name
Division Name
Email Address
Address
Telephone Number
Fax Number
Give the firm establishment registration number of the manufacturer listed above (if
known):
Enter brand names and/or model designations in the following table by clicking on the Add button. If you prefer to attach
a file, please click on the Add button and enter the text "See File Attachment" as the first table entry.
Item 1
Item 2
Item 3
List of Brand Names and/or Model Designations
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

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3632 Laser Product rpt (OMB 0910-0025)
Details

[HTML Text]

The Original Equipment Manufacturer (OEM) accession number (if known):
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these
numbers has been assigned by FDA yet.
[Multi-Line Plain Text]
If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please provide an
explanation. The device regulations can be found in 21 CFR 807 - device manufacturer registration and device listing.
[Multi-Line Plain Text]
Note:

See also http://www.fda.gov/MedicalDevices/default.htm for more information on medical device
premarket clearance procedures.

Section: Laser Product
PART 1: DEFINITIONS

GENERAL DEFINITIONS
This software application should be followed for all lasers and products containing, incorporating, or intended to incorporate, a laser
or laser system [see the definition of "laser product" in section 21 CFR1040.10(b)(21)]. A separate form for reporting additional
information concerning laser light shows is being published concurrently with this form and must be used in conjunction with this
form when appropriate (Reporting Guide for Laser Light Shows and Displays).

Laser Reporting and Recordkeeping (21 CFR 1002)
Applicability of reporting and recordkeeping requirements for laser products:
Class I, IIa, II, and IIIa laser products and laser products containing such lasers will require: Product Report, Annual Report, test
records,manufacturer's distribution records, and dealer/distributor distribution records.
Note that for Class I laser products containing lasers of Class I, IIa, II, or IIIa no Supplemental Reports are required. Furthermore,
some Class I laser products have already been exempted from the requirement for distribution records (see Notice to Industry dated
August 9, 1988, Laser Notice # 41).
Class IIIb and IV laser products require all of the above plus Supplemental Reports when the criteria requiring submission of
Supplemental Reports are met.
The laser standard applies to all laser products manufactured after August 1, 1976 (1040.10(a)), unless the products are either: sold
to a manufacturer for use as components (or replacements) in products that will be certified (1040.10(a)(l)); sold by or for a
manufacturer as repair or replacement components if they are properly labeled as such and have installation instructions
(1040.10)(a)(2)); or intended for export only, are labeled as such, and comply with the requirements of the importing country
(1010.20). Manufacturers of laser products that are sold to other manufacturers for use as components in their products are required
to register and list such products.

Laser Definitions from 21 CFR 1040.10(b)
Laser means any product that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but
less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to
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3632 Laser Product rpt (OMB 0910-0025)
1.0 x 10 to the power of 6 nm primarily by the process of controlled stimulated emission.
Laser energy source means any product intended for use in conjunction with a laser to supply energy for the operation of the laser.
General energy sources such as electrical supply mains or batteries shall not be considered to constitute laser energy sources.
Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to
incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall
itself be considered a laser product (1040.10(b)(21)).
Laser radiation means all electromagnetic radiation emitted by a laser product within the spectral range specified in
paragraph1040.10(b)(19) that is produced as a result of controlled stimulated emission or that is detectable with radiation so
produced through the appropriate aperture stop and within the appropriate solid angle of acceptance, as specified in 1040.10(e).
Laser system means a laser in combination with an appropriate laser energy source with or without additional incorporated
components. See paragraph 1040.10(c)(2) of the laser product performance standard for an explanation of the term "removable laser
system."

Specific-Purpose Products
Medical laser product means any laser product which is a medical device as defined in 21 U.S.C. 321(h) and is manufactured,
designed, intended or promoted for in vivo laser irradiation of any part of the human body for the purpose of: (i) Diagnosis, surgery,
or therapy; or (ii) relative positioning of the human body. Class IIIa, IIIb, and IV medical laser products must contain a means for
measuring the delivered exposure or treatment level of radiation, accurate within plus or minus 20 percent. This requirement is not
applicable to Class IIIa aiming devices except ophthalmic application.The instruction manual must include a procedure and schedule
for recalibration of the measurement system. A modified aperture label is also specified (1040.11(a)).
Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or
more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.
Surveying, leveling, and alignment laser products are generally used in agriculture and in the construction industry. They are
restricted to 5mW visible radiant power and to Class I for other wavelengths and pulses less than 3.8 x 10 to the power of negative 4
seconds (1040.11(b)).
Demonstration laser product means any laser product manufactured, designed, intended, or promoted for purposes of
demonstration, entertainment, advertising display, or artistic composition. The term "demonstration laser product" does not apply to
laser products which are not manufactured, designed, intended, or promoted for such purposes, even though they may be used for
those purposes or are intended to demonstrate other applications. Demonstration laser products (1040.10(b)(13)) include:
laser products promoted for classroom demonstration of optical phenomena;
artistic displays and their associated apparatus;
laser light show projectors; and
laser light shows and displays themselves.
A general-purpose, scientific, medical or industrial laser product is not considered to be a demonstration laser product when it is
demonstrated to a prospective purchaser. Demonstration laser products are restricted in their outputs to Class IIIa with its
accompanying restrictions to Class I for short pulses and invisible wavelengths(1040.11(c)). Because these levels are too low for
effective use in commercial theatrical lighting effects, CDRH may grant variances (1010.4) to manufacturers of laser light shows
and display devices. As a condition of the variance, the manufacturer must agree to adhere to several safety conditions to provide a
level of safety to the public equivalent to a fully compliant product. Consult the Compliance Guide for Laser Products, September
1985, Appendix B, Clarification of Certain Laser Light Show Requirements, for more information.

PART 2: PRODUCT AND MODEL IDENTIFICATION
2.1 Model Designation
Note:

Report the model name and/or number, model family, brand name, or other designation of the
product. If reporting a model family, provide the model designation of each model. If you do not use
a model family or brand name, leave the field blank.

Model Designation (Names and/or Numbers):

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3632 Laser Product rpt (OMB 0910-0025)
Item
Item 1

Item 2

2.2 Approval of Alternate Means
Does this document or any of its attachments contain:
An application for approval of alternate means of providing the equivalent or superior protection that a required
performance feature or labeling would provide (this is applicable to the beam attenuator requirements and
alternate labeling)?

[L]

What requirement are you requesting an approval of alternate means from?
[Multi-Line Plain Text]
Provide an explanation:
[Multi-Line Plain Text]

2.3 Product without a Laser
Is it a product that does not incorporate a laser but is intended to incorporate a laser?

[L]

If the product as introduced into commerce does not incorporate a laser, identify the manufacturer and models of the
laser that you recommend:
Item 1
Item 2
Item 3
Is it a product that is intended to be used with a laser?

[L]

If the product as introduced into commerce is intended to be used with a laser, identify the manufacturer and models of
the laser that you recommend:
Item 1
Item 2
Item 3
If you do not recommend a specific laser or laser system for use with the reported product, state the specifications of the
laser or laser system which may be used with your product. This would include wavelengths, power or energy levels,
etc.
[Multi-Line Plain Text]

2.4 Modification of a Laser Product
Note:

Modification involves any changes to the product that affect its classification, performance or labeling
requirements (as required by the standard or an approved variance).

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3632 Laser Product rpt (OMB 0910-0025)
Is your laser product the result of the modification of a laser product certified by another manufacturer?

[L]

2.4.1 Other Manufacturers
Item: 1 (could contain up to 20 items with none required)
Give the name and address and/or firm establishment registration number of the manufacturer:
[Multi-Line Plain Text]
Identify the model(s), and brand name(s):
Item 1
Item 2
Item 3
Provide the other manufacturer's accession number, if known:
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

2.5 Incorporation of Unmodified, Certified Laser Product
Does your laser product incorporate an unmodified, certified laser product?

[L]

2.5.1 Other Manufacturers
Item: 1 (could contain up to 20 items with none required)
Give the name and address and/or firm establishment registration number of the manufacturer:
[Multi-Line Plain Text]
Identify the model(s) and brand name(s):
Item 1
Item 2
Item 3
Provide the other manufacturer's accession number, if known:
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

2.6 Incorporation of Uncertified Laser Product
Does your laser product incorporate an uncertified laser product as a component or component subsystem?

[L]

2.6.1 Other Manufacturers

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3632 Laser Product rpt (OMB 0910-0025)
Item: 1 (could contain up to 20 items with none required)
Give the name and address and/or firm establishment registration number of the manufacturer:
[Multi-Line Plain Text]
Identify the model(s) and brand name(s):
Item 1
Item 2
Item 3
Provide the other manufacturer's accession number, if known:
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

2.7 Incorporation of Removable Laser System
Does your laser product incorporate a removable laser system or systems as defined by 21 CFR 1040.10(c)(2)?

[L]

2.7.1 Other Manufacturers
Item: 1 (could contain up to 20 items with none required)
Is the removable system certified?

[L]

Give the name and address and/or firm establishment registration number of the manufacturer:
[Multi-Line Plain Text]
Identify the model(s) and brand name(s):
Item 1
Item 2
Item 3
Provide the other manufacturer's accession number, if known:
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

Section: Technical Data
PART 3: DESCRIPTION OF THE PRODUCT
Note:

In this section, you are asked to provide descriptions of the product, its intended function, and the
laser radiation fields or paths and collateral radiation that may be accessible in operation,
maintenance, or service modes of the product. This section was previously Part 5 of the product
reporting guide.

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3632 Laser Product rpt (OMB 0910-0025)
3.1 Product Description and Function
Note:

You may refer to brochures and manuals submitted as attachments to this report.

Describe the product and its function:
File Attachment

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.zip)]

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3.2 External and Internal Laser Radiation Fields and Paths
Note:

Include beam path diagrams indicating protective housing, beam attenuators, viewports, scanners,
targets, etc. Indicate energy and power levels at locations inside and outside the product.

Describe the external and internal laser radiation fields and paths:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

3.3 Operational Procedures and Accessible Radiation
Note:

Describe here the procedures used during operation and the laser or collateral radiation that is
accessible during these procedures.

List the procedures performed during operation:
[Multi-Line Plain Text]
Do these procedures provide human access to ANY laser or collateral radiation?

[L]

Do the levels of laser or collateral radiation exceed the limits of Class I or Table VI?

[L]

Indicate those collateral and laser radiation fields to which human access is possible during those operation procedures.
Include the locations and identifications of laser and collateral radiation made accessible by viewing optics, viewports,
and display screens:
[Multi-Line Plain Text]

3.4 Maintenance Procedures and Accessible Radiation
Note:

Describe here the procedures used during maintenance and the laser or collateral radiation that is
accessible during these procedures.

List the procedures performed during maintenance:
[Multi-Line Plain Text]
Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI? [L]

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3632 Laser Product rpt (OMB 0910-0025)
Indicate those collateral and laser radiation fields to which human access is possible during those maintenance
procedures:
[Multi-Line Plain Text]

3.5 Service Procedures and Accessible Radiation
Note:

Describe here the procedures used during service and the laser or collateral radiation that is
accessible during these procedures.

List the procedures performed during service:
[Multi-Line Plain Text]
Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI? [L]
Indicate those collateral and laser radiation fields to which human access is possible during those service procedures:
[Multi-Line Plain Text]

PART 4: CERTIFICATION, CLASSIFICATION, AND LEVELS OF RADIATION
Note:

This section, covers the description of the certification and identification labels and the detailed
explanation of your classification of the product.

4.1 Performance Standard Identification
With which performance standard does your product comply?

[L]

4.2 Certification Label
Note:

Required on all laser products.

Is a certification label present on your product?

[L]

Does your certification label state that the product complies with the FDA performance standards except for
deviations pursuant to Laser Notice #50, dated July 26, 2001?

[L]

Attach a copy of the certification label with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

4.3 Identification Label
Note:

Required on all laser products.

Attach a copy of the identification label with an indication of its location on the product:
[Multi-Line Plain Text]
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File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

4.4 Performance Standard Classification
Under which laser product performance standard are you classifying your product?

[L]

4.5 Laser Product Class
Indicate the Class of the Laser Product:

[L]

4.6 Operation
Note:

For classification purposes describe the radiation levels accessible in any of the operational
configurations of the product.

4.6.1 Radiation Parameters
Item: 1 (could contain up to 10 items with none required)
Give specifications of laser radiation fields to which human access is possible during operation (please provide as much
of the following as is appropriate to your product).
Identify which laser is being described.
Primary lasing medium or laser type:

[L]

If other, then please specify:
Primary wavelength (nm):
Maximum average radiant power (W):
Beam divergence, if symetric:
Beam divergence, if asymetric (horizontal/vertical):
Beam diameter at laser aperture (mm):
Is the laser output pulsed?

[L]

Pulse energy (J):
Peak power (W):
Pulse duration (sec):
Repetition rate (Hz):
Maximum irradiance (W/cm2):
Maximum radiant exposure (J/cm2):
Maximum radiance (W/cm2sr):
Maximum integrated radiance (J/cm2sr):

4.6.2 Basis of Reported Values
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3632 Laser Product rpt (OMB 0910-0025)
The values reported for the laser product are based on:

[L]

Provide a diagram of your measurement set-up or the analysis used in your calculations. Provide pertinent dimensions
such as separation distances, source and detector aperture size, etc. to show compliance with the standard under which
you are classifying:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

4.7 Embedded Laser System
Note:

Describe here laser radiation fields contained within the protective housing of the product which may
exceed the class of the product. The classification of the contained laser radiation is pertinent to
safety interlock and protective housing label requirements.

4.7.1 Internal Radiation Levels
Does the protective housing contain radiation in excess of the Class of the product (such as in a product that has
a higher class laser embedded inside, such as a laser printer or workstation)?

[L]

4.7.2 Classification of Embedded Laser Radiation
Give the classification of laser radiation contained by the protective housing:

[L]

4.7.3 Radiation Parameters
Item: 1 (could contain up to 10 items with none required)
Give specifications of laser radiation fieldscontained by the protective housing (please provide as much of the following
as is appropriate to your product).
Identify which laser is being described.
Primary lasing medium or laser type

[L]

If other, then please specify:
Primary wavelength (nm):
Maximum average radiant power (W):
Beam divergence, if symetric:
Beam divergence, if asymetric (horizontal/vertical):
Beam diameter at laser aperture (mm):
Is the laser output pulsed?

[L]

Pulse energy (J):
Peak power (W):
Pulse duration (sec):
Repetition rate (Hz):
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3632 Laser Product rpt (OMB 0910-0025)
Maximum irradiance (W/cm2):
Maximum radiant exposure (J/cm2):
Maximum radiance (W/cm2sr):
Maximum integrated radiance (J/cm2sr):

4.7.4 Other Radiation Fields
Are their other radiation fields to be described?

[L]

Please describe other radiation fields:
[Multi-Line Plain Text]

4.7.5 Basis of Reported Values
The values reported for the laser product are based on:

[L]

Provide a diagram of your measurement set-up or the analysis used in your calculations. Provide pertinent dimensions
such as separation distances, source and detector aperture size, etc. to show compliance with the standard under which
you are classifying:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

4.8 Maintenance
Note:

Describe here the laser radiation fields accessible in maintenance configurations of the laser product.

4.8.1 Radiation Class during Maintenance
Indicate the Class of the laser radiation accessible during maintenance:

[L]

4.8.2 Radiation Parameters
Item: 1 (could contain up to 10 items with none required)
Give specifications of laser radiation fields to which human access is possible during maintenance (please provide as
much of the following as is appropriate to your product).
Identify which laser is being described.
Primary lasing medium or laser type

[L]

If other, then please specify:
Primary wavelength (nm):
Maximum average radiant power (W):
Beam divergence, if symetric:

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3632 Laser Product rpt (OMB 0910-0025)
Beam divergence, if asymetric (horizontal/vertical):
Beam diameter at laser aperture (mm):
Is the laser output pulsed?

[L]

Pulse energy (J):
Peak power (W):
Pulse duration (sec):
Repetition rate (Hz):
Maximum irradiance (W/cm2):
Maximum radiant exposure (J/cm2):
Maximum radiance (W/cm2sr):
Maximum integrated radiance (J/cm2sr):

4.8.3 Basis of Reported Values
The values reported for the laser product are based on:

[L]

Provide a diagram of your measurement set-up or the analysis used in your calculations. Provide pertinent dimensions
such as separation distances, source and detector aperture size, etc. to show compliance with the standard under which
you are classifying:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[Multi-Line Plain Text]

4.9 Service
Note:

Describe here the laser radiation fields accessible in service configurations of the laser product.

4.9.1 Radiation Class during Service
Indicate the Class of the laser radiation accessible during service:

[L]

4.9.2 Radiation Parameters
Item: 1 (could contain up to 10 items with none required)
Give specifications of laser radiation fieldsto which human access is possible during service (please provide as much of
the following as is appropriate to your product).
Identify which laser is being described.
Primary lasing medium or laser type

[L]

If other, then please specify:
Primary wavelength (nm):

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3632 Laser Product rpt (OMB 0910-0025)
Maximum average radiant power (W):
Beam divergence, if symetric:
Beam divergence, if asymetric (horizontal/vertical):
Beam diameter at laser aperture (mm):
Is the laser output pulsed?

[L]

Pulse energy (J):
Peak power (W):
Pulse duration (sec):
Repetition rate (Hz):
Maximum irradiance (W/cm2):
Maximum radiant exposure (J/cm2):
Maximum radiance (W/cm2sr):
Maximum integrated radiance (J/cm2sr):

4.9.3 Basis of Reported Values
The values reported for the laser product are based on:

[L]

Provide a diagram of your measurement set-up or the analysis used in your calculations. Provide pertinent dimensions
such as separation distances, source and detector aperture size, etc. to show compliance with the standard under which
you are classifying:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

4.10 Collateral Radiation
Describe all collateral radiation fields associated with the product. Report the source(s) and levels and describe where
and under what circumstances such radiation is accessible:
[Multi-Line Plain Text]
Provide a diagram of yourmeasurement set-up or the analysis used in your calculations. Provide pertinent dimensions
such as separation distances, source and detectoraperture size, etc. to show compliance with the standard under which
you are classifying:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

PART 5: COMPLIANCE WITH PERFORMANCE REQUIREMENTS
Note:

In this section, you will describe how your product complies with the performance requirements. This
section was previously Part 7 of the product reports.

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3632 Laser Product rpt (OMB 0910-0025)
5.1 Protective Housing
Note:

Required for all classes of laser products (see 1040.10(f)(1) and Compliance Guide).

Describe the product's protective housing and how it serves to prevent unnecessary human access to levels of laser
radiation in excess of Class I:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Describe how the protective housing prevents access to unnecessary collateral radiation in excess of Table VI:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.2 Safety Interlocks
Note:

Applicable for all Classes of laser products (see 1040.10(f)(2)(i) and Compliance Guide).

Does your product have portions of the protective housing that are intended to be opened or removed for:
Operation:

[L]

Maintenance:

[L]

Service:

[L]

Does your laser product incorporate any safety interlocks?

[L]

What types of interlocks (select all that apply):
Item 1
Item 2
Item 3
If other, then please specify:
Provide an electrical block diagram illustrating the logic of all interlock systems:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Provide a detailed mechanical diagram showing where they all are located on the product:
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.2.1 Safety Interlock Types

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3632 Laser Product rpt (OMB 0910-0025)
What type of safety interlock is this?

[L]

Is this optional?

[L]

Non-Defeatable Safety Interlocks
With which laser product performance standard does this type comply?

[L]

Select how this type operates:

[L]

If other, please explain how it operates:
Is this type designed to allow defeat?

[L]

Actuated during:
Item 1
Item 2
Item 3
To what radiation level does this type prevent access?
[Multi-Line Plain Text]
Defeatable Safety Interlocks
Note:

Applicable to all laser products (see 1040.10(f)(2)(ii) and (iii)and ComplianceGuide).

How does each interlock preclude replacement of the housing while that interlock is defeated?
[Multi-Line Plain Text]
Describe the means of providing a visible or audible indication of defeat:
[Multi-Line Plain Text]
Fail Safe or Redundant Safety Interlocks
Note:

Applicable to all required safety interlocks that prevent access to Class IIIb or IV (IEC: 3b and 4)
levels of laser radiation. (see 1040.10(f)(2)(iii).

Describe how each safety interlock is "fail-safe," (i.e., precludes removal or displacement of the interlocked portion of
the protective housing upon failure of the safety interlock or is redundant):
[Multi-Line Plain Text]
Describe the possible modes of failure of each safety interlock and the resultant effect upon the radiation safety of the
laser product:

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3632 Laser Product rpt (OMB 0910-0025)
[Multi-Line Plain Text]
State the rating of each safety interlock, including the number of operational cycles before failure:
[Multi-Line Plain Text]

5.3 Remote Interlock Connector
Note:

Applicable to Class IIIb or IV (and IEC:3B and 4) laser systems (see 1040.10(f)(3) and Compliance
Guide).

Does the product have a remote interlock connector that disables the laser radiation when the circuit is open?

[L]

Describe the electrical and mechanical construction and operation of the remote connector (give its circuit and physical
location):
[Multi-Line Plain Text]
Record the open-circuit electrical potential difference between the terminals of the remote interlock connector:

5.4 Security Master (Key) Control
Note:

Required for Class IIIb or IV (and IEC:3B or 4) laser systems (see 1040.10(f)(4) and Compliance
Guide).

Does your product have a Security Master control?

[L]

What type of security control is it?

[L]

If other, then please specify:
Describe how it works,including how the key control prevents unauthorized use of the product:
[Multi-Line Plain Text]
Is the key control removable in the "On" position?

[L]

Describe the function of the key control and how it renders the laser inoperable when the "key" is removed:
[Multi-Line Plain Text]

5.5 Laser Radiation Emission Indicator
Note:

Required for Class II, IIIa, IIIb, or IV (and IEC: 3R, 3B, and 4) laser systems (see 1040.10(f)(5)
andCompliance Guide).

Does the product incorporate any emission indicators?

[L]

Describe in detail the mechanical and electrical characteristicsof all emission indicators installed pursuant to Section
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3632 Laser Product rpt (OMB 0910-0025)
1040.10(f)(5)(i) or (ii) and give their locations:
[Multi-Line Plain Text]
What type of emission indicator is incorporated?

[L]

If "other", please describe:
[Multi-Line Plain Text]
How is your emission indicator warning fail-safe or redundant?
[Multi-Line Plain Text]

5.5.1 Separation of Laser and Operation Control
Are the laser head, laser energy source or operation controller(s) separable by more than 2 meters?

[L]

Does the laser head and each control have an emission indicator?

[L]

5.5.2 Emission Delay
Note:

Requiredfor Class IIIb and IV(and IEC: 3B and 4) (see 1040.10(f)(5)(ii) and Compliance Guide).

Is there a specific delay betweenthe indication of emission and the actual emission? [L]
How is emission delay achieved?

[L]

If other, then please explain further:
Please provide additional information, as needed:
[Multi-Line Plain Text]
How many seconds is the emission indicator actuated priorto laser emission?

5.5.3 Emission Indicator Visibility through Protective Eyewear
Note:

Applicable to Class II, IIIa, IIIb or IV (and IEC: 3R, 3B, and 4) laser systems [1040.10(f)(5)(iv)].

Is protective eyewear supplied with the laser system?

[L]

Is protective eyewear recommended?

[L]

Can all visible emission indicators be seen through eyewear?

[L]

5.6 Beam Attenuator
Note:

Required for Class II, IIIa, IIIb or IV (and IEC: 3B or 4) laser systems (see 1040.10(f)(6) and
Compliance Guide).

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3632 Laser Product rpt (OMB 0910-0025)
Note:

You may be able to use currently approved alternate means or you may need to apply for approval of
alternate means of providing this protection if this alternate means provides protection equivalent to a
beam attenuator.

Does your product have a beam attenuator?

[L]

Does your product have an alternative?

[L]

Describe or attach request for approval of alternate means:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.6.1 Beam Attenuator Description
Item: 1 (could contain up to 20 items with none required)
Does your product incorporate any of the following:

[L]

For the beam attenuator, describe the mechanical and electrical characteristics:
[Multi-Line Plain Text]
Does the attenuator prevent access by any part of the human body to all laser and collateral radiation in excess
of the accessible emission limits of Class I and Table VI?

[L]

Describe how it does this:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Describe how the beam attenuator is permanently attached:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.7 Location of Controls
Note:

Applicable to Class II, IIIa, IIIb or IV laser products (see 1040.10(f)(7) and Compliance Guide).

Are operational and adjustment controls located so that exposure to laser radiation, above the accessible
emission limits of Class I and Table VI, is unnecessary?

[L]

Describe:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

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3632 Laser Product rpt (OMB 0910-0025)
5.8 Viewing Optics
Note:

Applicable to all laser products (see 1040.10(f)(8)and Compliance Guide).

Does the product incorporate any of the following viewing optics:

[L]

If so, please further describe the viewing optic that is incorporated:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Is the laser and collateral radiation that is accessible by virtue of viewing optics, viewports, or
display screens less than the accessible emission limits of Class I and Table VI during operation
and maintenance?

[L]

Provide calculations and/or measurements,including pertinent attenuation factors, window transmission characteristics,
etc.:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.8.1 Attenuation of Viewing Optics
Do the viewing optics, viewports, or display screen incorporate a shutter or variable attenuator?

[L]

Describe in detail, using diagrams or photographs and radiation transmission or reflection spectra, each shutter or
variable attenuator incorporated into viewing optics, viewport, or display screen:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Describe how exposure of the eye to laser or collateral radiation in excess of the accessible emission limits of Class I (or
IEC: 1M) and Table VI is prevented, for the following:
In the event of failureof the shutter or variable attenuator, as required by Section 1040.10(f)(8)(ii):
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Whenever the shutter is opened or the attenuator is varied:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.9 Scanning Safeguard
Note:

Required for certain laser products with scanned laser radiation (see 1040.10(f)(9) and Compliance
Guide).

Note:

A safeguard is required when scan failure would cause the product to exceed the emission limits of its
class.

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3632 Laser Product rpt (OMB 0910-0025)
Does the product incorporate a scanning safeguard?

[L]

Describe the mechanical, electrical, and functional characteristics of any required scan failure safeguard:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Is the classification of the product based on the level of scanned radiation?

[L]

What is the reaction time?
Provide calculations to show that the safeguard's reaction time is adequate to prevent human access to laser radiation
in excess of the product's class:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.10 Manual Reset
Note:

Applicable to Class IV laser systems manufactured after August 20, 1986. (see 1040.10(f)(10) and
Compliance Guide).

Does the product incorporate a manual reset mechanism or means that prevents automatic restart following
interruptionof emission caused by power failure of at least 5 seconds or deactivationthrough the remote interlock
connector?

[L]

Provide the circuit and physical description and location of the manual reset mechanism:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Does emission delay reactivate when power is resumed after an interruption of 5 seconds or more?

[L]

Must the emission be manually restarted following interruption via the remote interlock connector?

[L]

5.11 Medical Laser Product
Note:

Applicable to Class III or IV (and IEC: 3B or 4) medical laser products intended for in-vivo surgical,
therapeutic, or diagnostic irradiation of the human body (see 1040.11(a) and Compliance Guide).

Note:

The requirement in section 1040.11(a) does not apply to visible aiming beams less than the
accessible emission limits of Class IIIa except for ophthalmic indications.

Describe the means incorporated into the product to measure the level of laser radiation intended for irradiating the
human body; include circuit diagrams and/or optical system diagrams:
[Multi-Line Plain Text]

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3632 Laser Product rpt (OMB 0910-0025)
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.11.1 Laser Radiation Levels
Is the radiation level continuously monitored?

[L]

Explain how the radiation level is monitored:
[Multi-Line Plain Text]
Describe how the system can assure the accuracy of the displayed value to within 20%:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[Multi-Line Plain Text]

5.11.2 Measurement and Monitoring Uncertainties
Specify the uncertainty in the measurement system and describe the method by which it was derived:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Specify the uncertainty in the monitoring system and describe the method by which it was derived:
[Multi-Line Plain Text]
Describe how the displayed power/energy level is either measured at the point of delivery or measured earlier and then
the actual output calculated:
[Multi-Line Plain Text]
If the displayed level is calculated, then provide calculations incorporating system constants, losses, attenuation factors,
etc. to demonstrate accurate calibration of the delivered beam to +/-20%:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.11.3 Calibration Procedures
Are procedures and a schedule for recalibration of the measurement system included in the user instructions?

[L]

Identify location in the user instructions:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

5.12 Surveying, Leveling, or Alignment Laser Products
Note:

As a surveying, leveling, or alignment laser product it is subject to the requirements of section
1040.11(b).

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3632 Laser Product rpt (OMB 0910-0025)
Note:

If the product's class exceeds Class IIIa then an approved variance from the performance
requirements in this section would be necessary prior to introduction into commerce.

Is a variance request being submitted with this report?

[L]

5.13 Demonstration Laser Products
Note:

As a demonstration laser product it is subject to therequirements of section1040.11(c).

Note:

If the product's class exceeds Class IIIa then an approved variance from the performance
requirements in this section would be necessary prior to introduction into commerce.

Note:

An Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show,Display, or Device
(form FDA 3147) must be submitted, following the instructions on the form. ALaser Light Show report
may also be required for Class IIIb or IV shows or displays.

Is a Laser Light Show report being submitted along with this report?

[L]

Is a variance application for a laser light show projector and laser light show being submitted along
with this report?

[L]

Does its user instructions include a warning not to direct the laser radiation at the audience?

[L]

PART 6: COMPLIANCE WITH LABELING REQUIREMENTS
Note:

In this section, you will describe how your product complies with the labeling requirements. This
section was previously Part 3 of the product reporting guide.

Note:

For each of the following labels required for the product being reported, provide a sample or a
facsimile of each label. Clearly indicate the locations on the product of allrequired labels. Submitting
diagrams, photographs, blueprints, product literature, etc. is acceptable (see laser notices # 16, 17,
45, and 50).

6.1 Performance Standard Identification
With which performance standard do your product's labels comply:

[L]

6.2 Warning Logotype Label
Note:

Required on Class II, III, and IV laser products. (see 1040.10(g)(1), (2),(3),(4),(8),(9),(10) and
Compliance Guide).

Attach a copy with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

6.3 IEC Warning Label

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3632 Laser Product rpt (OMB 0910-0025)
Note:

Required on all Class 1, 1M,2, 2M, 3R, 3B, and 4 laser products.

Attach a copy of both labels with an indication of their locations on the product.
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

6.4 Class IIa Warning Label
Note:

Required on Class IIa laser products (see 1040.10(g)(1)(i) and Compliance Guide).

Attach a copy with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

6.5 Aperture Label
Note:

Required on Class II, III and IV (IEC: 3R, 3B, and 4) laser products (for nonmedical laser products see
1040.10(g)(5),(8),(9),(10) or for medical laser products see 1040.11(a)(3) and Compliance Guide).

Attach a copy with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

6.6 Protective Housing Labels
Note:

See 1040.10(g)(6),(7),(8),(9),(10), Compliance Guide, and Laser Notice 17.

Does your product have any protective housing labels?

[L]

Does your product have any noninterlocked protective housing labels?

[L]

Attach a copy with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Indicate how the label(s) are visible both prior to and during opening or removal of housing:
[Multi-Line Plain Text]
Does your product have any defeatably interlocked protective housing labels?

[L]

Attach a copy with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Indicate how the label(s) are visible both prior to and during interlock defeat:
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3632 Laser Product rpt (OMB 0910-0025)
[Multi-Line Plain Text]
Does your product have any optionally interlocked protective housing labels?

[L]

Attach a copy with an indication of its location on the product:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Indicate how the labels are visible both prior to and during opening or removal of the housing:
[Multi-Line Plain Text]

PART 7: COMPLIANCE WITH INFORMATIONAL REQUIREMENTS
Note:

In this section, you will describe how your product complies with the informational requirements. This
section was previously Part 4 of the product reporting guide.

7.1 User Information
Submit a copy of user information (operator's manuals) for your laser product. If the manual is very extensive, submit
those portions that confirm compliance with Section 1040.10(h) [and 1040.11(a)(2), if a medical laser product]:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Does the manual contain adequate instructions for assembly, operation, and maintenance?

[L]

Does it contain clear warnings to avoid exposure?

[L]

Does it contain a statement of output parameters?

[L]

Does it contain legiblereproductions of all labels, their locations on the product, and hazard
warnings?

[L]

Does it contain a listing of controls, adjustments, and procedures for operation and maintenance?

[L]

Does it contain a schedule of maintenance?

[L]

Does it contain the "Caution - use of controls..." warning statement?

[L]

Does it include information to determine nominal hazard zone for users?

[L]

Does it contain a compatibility statement concerning recommended lasers or specifications?

[L]

Does it contain an additional warning stating that viewing the laser output with optical instruments
may result in an eye hazard for Class 1M or an increased hazard for Class 2M?

[L]

Note:

These materials may also have been used in the product description required by Part 3.

7.2 Promotional Literature
Submit copies of any sales literature, including catalogs, specification sheets, and descriptive brochures for Class IIa, II,
III, and IV laser products:
[Multi-Line Plain Text]
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3632 Laser Product rpt (OMB 0910-0025)
File Attachment
Note:

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]
This material is needed to demonstrate compliance with Section 1040.10(h)(2), which states that a
reproduction of the warning logotype is required in all catalogs, specification sheets, and descriptive
brochures.

7.3 Servicing Information
Submit a copy of the relevant radiation safety sections of your product's servicing information (from your service
manual):
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Section: Quality Control
PART 8: PRODUCT DESIGN VERIFICATION
Note:

In this section, any attached files must identify the manufacturing facility and name of the responsible
Quality Assurance manager for the activity. This section waspreviously Part 9 of the laser product
reporting guide.
In this section, you will also describe those design considerations, verification activities, and controls
implemented to ensure that the reported product will remain in compliance with the Federal laser
product performance standard during its useful life.
Quality control and product testing should be based on design considerations and factors that can
affect product compliance with the Federal laser product performance standard.

8.1 Critical Design Requirements
List the factors identified during design that may provide product compliance with the Federal laser product performance
standard or performance as related to accessible or emitted laser radiation (e.g. performance specifications, component
selection):
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

8.2 Life Testing
Note:

In this section you will describe those verification activities conducted to assure product compliance
with the Federal laser product performance standard over its useful life.

Note:

Maintenance and/or service instructions must include schedules for maintenance and replacement of
components that may be necessary for the compliance of the product during its useful life.

Testing of features designed to meet Federal laser product performance requirements:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Acceptance of electrical and electronic components:
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3632 Laser Product rpt (OMB 0910-0025)
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Dimensional stability and rigidity of mechanical parts and assemblies such as housings and mounts:
[Multi-Line Plain Text]
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Environmental stability of components such as filter materials, coatings,and adhesives:
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Other factors that might affect your product's radiation safety:
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Provide an estimate of the useful life of the product (in years):

8.3 Change Controls
Describe the controls implemented to assure compliance with the Federal laser product performance standard (e.g.
control of design changes, user and service information changes, labeling changes to assure that compliance of the
product is not jeopardized.):
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PART 9: QUALITY CONTROL TESTS AND PROCEDURES
Note:

In this section, any attached files must identifythe manufacturing facility and name of the responsible
Quality Assurance manager for the activity. This section was previously Part 8 of the laser product
reporting guide.
Section 1010.2(c) requires that certification be based on a test, in accordance with the standard, of
each unit or on a program in accordance with good manufacturing practices.
Failure to maintain an adequate testing program may result in disapproval of the program by CDRH.

9.1 Quality Control Documentation
Note:

Attach samples of documents that describe, specify, or relate to procedures or tests used to ensure
compliance of your reported product with the standard, including compliance with all performance,
labeling, and informational requirements.

Specification controls for critical components:
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Manufacturing and assembly control procedures:
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Inspection and test control procedures:
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Assembly and test traveler forms:
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Inspection and test reports and checklists:
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Other(s), specify:
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9.2 Alternate Quality Control Procedures
If formal quality control and testing procedures have not been implemented or are not sufficient to assure that your
product(s) will comply with the standard, explain how you assure that your products comply and submit supporting
documentation:
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PART 10: INSTRUMENTATION AND CALIBRATION
Note:

In this section, you will describe the instrumentation used for compliance testing your product and the
instrumentation calibration procedures.

10.1 Component Testing
Do you purchase components or services from contractors or original equipment manufacturers in lieu of
conducting your own in-house testing?

[L]

Provide certificates or sample test/inspection records from suppliers or original equipment manufacturers, etc. to assure
that those entities are operating in a state of control.
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3632 Laser Product rpt (OMB 0910-0025)
Describe those tests and controls used to determine whether the reported product is producedto be in compliance with
the Federal laser product performance standard:
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Do you conduct in-house compliance testing for your product?

[L]

Do you have testing done by an outside contractor?

[L]

10.2 Compliance Testing
Describe those tests and controls used to determine whether the reported product is produced to be in compliance with
the Federal laser product performance standard:
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List the instruments you use to determine compliance of the reported product with the standard. Describe these
instruments or provide copies of specification sheets. Identify each detector's aperture size, if applicable.
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Indicate how the measurement system collects or accounts for the total radiant energy or power specified in Section
1040.10(e):
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Provide a measurement error analysis (for all sources of error identified) and an uncertainty statement for all
measurement data reported. (If it isclear from the measurement data, including the total estimated uncertainty, that the
levels are well below the applicable class limit, then an error analysis and uncertainty statement are not required. For
example, an error analysis and uncertainty statement would not be required for a 1.5 milliwattHeNe laser product
classified in Class IIIa.):
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10.3 Calibration
Provide instrument calibration schedules and indicate how your instruments are calibrated (e.g.,calibrated by your
company against a working standard, returned to the manufacturer of the instrument, sent to an independent calibration
laboratory) [If your laser product operates at a level closely approaching a specified limit, high accuracy and traceabilty
to the National Institute of Standards and Technology (previously known as the National Bureau of Standards) are
important]:
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3632 Laser Product rpt (OMB 0910-0025)
Stop:

You have reached the end of this report. Please verify that all PDFs that are to be included in this
submission are correctly attached to a specific file attachment question. Otherwise, they will not be
packaged with your report. Check to make sure you have no missing data (select Missing Data
Report from the Output menu). Once you have confirmed that there is no missing data and all your
files are attached, click on the Package Submission icon on the tool bar.

Message:

Form FDA 3632 Guide for Preparing Product Reports on Lasers and Products Containing Lasers
(10/31/2013)

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:12 PM

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