3632 Lasers and Products Containing Lasers Product Report

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OMB No. 0910-0025; Exp. May 31, 2010
Section: eRadHealth Menu

Role

What is your role?
Note:

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

Submission Information

FDA or State Inspector

Abbreviated Report Applicability

OEM Laser Applicability

Section: Manufacturer Data

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, when you submit through it you will receive
your acknowledgement email message with Accession Number within minutes!

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Information about the FDA Electronic Submissions Gateway can be found at www.fda.gov/esg. 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.
You should be familiar with the regulatory requirements for radiological products at
www.fda.gov/cdrh/radhealth/ and medical devices available at www.fda.gov/cdrh/devadvice/. 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).
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

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accession number that CDRH assigns to the report. Please reference this accession number in the
future when providing 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.
We are providing our new software applications for the old reporting forms upon request during this
beta testing period of development in Spring, 2005. Other regulatory information is still available on
the Internet under www.fda.gov/cdrh/radhealth/. 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).
Definitions

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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:
z

z
z
z

z

z
z
z

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.

Accidental Radiation Occurrences
An accidental radiation occurrence means a single event or series of events that has/have resulted in
injurious or potentially injurious exposure of any person to electronic product radiation as a result of
the manufacturing, testing, or use of an electronic product.

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
It shall be the duty of every manufacturer offering an electronic product for importation into the United

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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 effective shielding or other controls would emit) such radiation.
Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 26 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
"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."

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Manufacturer and Report Information

Information:

This general 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. You can check for missing
data using the "Missing Data" report from the "Output" menu.
If you are acting as an agent or consultant for another firm who is certifying the product (or laser light show), please enter the
certifying manufacturer and list yourself as the report submitter, below.

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.

Select the Manufacturer's address from the Establishment Address book:
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Responsible Individual

Note:

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

Select the Responsible Individual from the Contact Address book:

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Report Submitter

Note:

The submitter maybe a consulting individual or firm providing assistance in report preparation and maintenance. All
documents prepared by the submitter must have the manufacturer's reporting official signature for authenticity of submitted

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documentation.
Select the Submitter from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Comments:

Internal Reference Number:

Parent Establishment

Is there a parent establishment?

[L]

Select the Parent Establishment and Contact from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:

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Address

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:

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 Information:
Contact Name
Occupation Title
Email Address
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:
Contact Information:
Contact Name
Occupation Title
Email Address

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Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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:
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Comments:

Code used on identification labels:

Section: Product Data

Product and Model Identification

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At this time we are only accepting electronic versions of reporting guides contained within this software. Other reporting
guides that are not yet electronic are available for downloading from http://www.fda.gov/cdrh/comp/eprc.html.

Product Type Reported

Report Information

Is this submission a supplement to an Annual Report submitted previously for the same reporting year?

[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.)

Please verify that your accession number matches the report type that is being filed. The third
character of your accession number must correspond with its associated report type as shown in
the table below:
Report Type Description:

Third Character:

Initial Product Report

1

Model Change Product Report

2

Annual Report

3

Abbreviated Report

8

Variance Request

A

Laser OEM Registration and Listing Report R
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, Other" as your Type of Submission in the Submission Information Screen. If you select "Variance Request, Other"
you must select the product for which you are requesting a variance at the end of the screen.

Special Considerations

Note:

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

Noncompliances or Defects

Does this document or any of its attachments contain:
A self-declaration or notification of noncompliance or defect?

[L]

Provide an explanation:

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[Multi-Line Plain Text]

Responses to Noncompliances or Defects

Does this document or any of its attachments contain and of these responses concerning noncompliances?
A refutation of noncompliances?

[L]

A request for an exemption from notification?

[L]

Corrective action plans you may be conducting?

[L]

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

[L]

Provide an explanation:
[Multi-Line Plain Text]

Exemption Requests

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

[L]

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

[L]

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

[L]

Request for approval of alternate labeling?

[L]

Application for alternate test procedures (1010.13)?

[L]

Provide an explanation:
[Multi-Line Plain Text]
Attach any necessary files.
[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

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]

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File Attachment
Stop:

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

[L]

What was the date of the inspection?

[Date]

A response to a warning letter from the Food and Drug Administration (FDA)?

[L]

What was the date of the Warning Letter?

[Date]

A response to a report review inquiry from the Center for Devices and Radiological Health (CDRH) (the inquiry may have

[L]

been in the form of a letter, email, or phone call)?
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
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?

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[L]

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Private Labeling-Table

Item: 1 (could contain up to 20 items with 1 required)

Give the name and address of the manufacturer:
Establishment Information:
Establishment Name
Division Name
Email Address
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)]

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 assigned yet, provide an explanation and submit it as soon as you receive such a filing number.
[Multi-Line Plain Text]

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See www.fda.gov/cdrh for more information onmedical device premarket clearance procedures.

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.

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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
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.
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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):
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?
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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).

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
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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
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

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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.

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

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

Details

[HTML Text]

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

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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]
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

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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]
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)

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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
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)?
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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):
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
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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:
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:

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[L]

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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):
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
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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.

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:
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[L]
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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
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?

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[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:
[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
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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
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).

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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).

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

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

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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.

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).

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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]
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:
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[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).

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]

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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
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:
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[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:
[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]
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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]
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

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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:
[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]
File Attachment

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

Environmental stability of components such as filter materials, coatings,and adhesives:
[Multi-Line Plain Text]
File Attachment

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

Other factors that might affect your product's radiation safety:
[Multi-Line Plain Text]
File Attachment

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

Provide an estimate of the useful life of the product (in years):

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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.):
[Multi-Line Plain Text]
File Attachment

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

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:
[Multi-Line Plain Text]
File Attachment

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

Manufacturing and assembly control procedures:
[Multi-Line Plain Text]
File Attachment

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

Inspection and test control procedures:
[Multi-Line Plain Text]
File Attachment

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

Assembly and test traveler forms:
[Multi-Line Plain Text]
File Attachment

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

Inspection and test reports and checklists:
[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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Other(s), specify:
[Multi-Line Plain Text]
File Attachment

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

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:
[Multi-Line Plain Text]
File Attachment

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

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.
[Multi-Line Plain Text]
File Attachment

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

Describe those tests and controls used to determine whether the reported product is producedto be in compliance with
the Federal laser product performance standard:
[Multi-Line Plain Text]
File Attachment

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

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:
[Multi-Line Plain Text]
File Attachment

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

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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File Attachment

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

[Multi-Line Plain Text]
Indicate how the measurement system collects or accounts for the total radiant energy or power specified in Section
1040.10(e):
[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 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.):
[Multi-Line Plain Text]
File Attachment

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

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]:
[Multi-Line Plain Text]
File Attachment

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

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
(03/06)

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 3/31/2010 at 10:12 AM

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