3632 Laser Product Report

Submission Report
Section: Main Menu
Welcome

Welcome to the CDRH Electronic
Submissions Software (CeSub)
This software application is intended to automate the current paper submission process.
This software contains a number of data capturing tools and helpful dialog boxes to
reduce redundant responses for you, and to allow us to capture data in a more useful,
structured format. These benefits will enable CDRH to improve our review process and
reduce lengthy review times.
For your convenience, an email account has been established to support any questions
that you may have regarding the use of this software. Please email any questions or
comments to the CeSub team at: [email protected]. Please be sure to include your
name, company name and contact information in the email.
Thank you again for using our electronic product reporting software. We look forward to
hearing from you soon.
What type of product is this submission referring to?

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Radiation Emitting Product (OMB No. 0910-0025; Expiration Date: December 31, 2006)

Welcome (Cont.)

Department of Health and Human Services
Food and Drug Administration

Form Approved:
OMB Number 0910-0025
Expiration Date: December 31, 2006
Section: eRadHealth Menu
Role
What is your role?

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Manufacturer

Submission Information
What Type of Submission is this? (Supplements should be submitted selecting the same document type as the original
report.)

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Radiation Safety Report (Product Report)
What Type of Product is this Annual Report about?

What Type of Correspondence is this?

What Type of Product is this Radiation Safety Report about?
Laser Products (Includes Projection Systems)
What Type of Product is this Variance Request about?

What Laser Light Show Documents are you filing?

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 CDRH Electronic Submission (CeSub) software is the next version of the
application the CDRH is developing 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.
We have already received many electronic submissions and are looking forward to
receiving more in the future. With this new release of the software we have updated our
procedures for packaging a submission to make this a smoother process for all. All
electronic reports (your new CD-ROMs) and any other documents you are submitting in
hard copy because they cannot be provided in an acceptable electronic format must be
mailed to CDRH. A signed hard copy of the submittal letter generated by the submission
software, should be printed out and included with your electronic submission. This
printed documentation will provide the Document Control Room with enough
information to log the submission. The electronic submissions should be sent directly to
the Document Control room, which is the same process for the standard paper

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submission.
The submission must be addressed to:
Electronic Product Document Control (HFZ-309), Attn: CeSub Team, Center for
Devices and Radiological Health, 2094 Gaither Road, Rockville, MD 20850
After sending your submission to the Document Control Room, please send an email to
the [email protected] email account so we will know that your submission is
forthcoming. Please remember that all correspondence concerning your submission
MUST be sent to the Electronic Product Document Control (HFZ-309), at the above
letterhead address. Correspondence sent to any address other than the one above will not
be considered as part of your official notification submission. Please refer to this
guidance for information on current fax and e-mail practices at
www.fda.gov/cdrh/ode/a02-01.html. You should also be familiar with the regulatory
requirements for radiological products at www.fda.gov/cdrh/comp/eprc.html and medical
devices available at Device Advice www.fda.gov/cdrh/devadvice/.
If you have specific questions regarding the software, please contact the CeSub team by
email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your
comments and criticisms to the CeSub team as often as you like.
Thank you for your continued support of the CDRH eSubmission Pilot Program.
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
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
http://www.fda.gov/cdrh/comp/eprc.html. 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 the address
below.
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

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:
•
•
•
•
•

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•
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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 Act
Sec 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 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 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:
Food and Drug Administration CDRH (HFZ-240)
1350 Piccard Drive Rockville, MD 20850

Please DO NOT RETURN this application to this address.
"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 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.

Copy from the establishment address book
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number

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Fax Number
Mailing Location:
Address

Responsible Individual
Note:

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

Copy from 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.

Copy 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

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Electronic Signature
Electronic signature (not available in this release of the software)

File Attachment

Report Submitter
Note:

The submittermaybe 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 documentation.

Copy from contact address list

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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

Parent Establishment
Is there a parent establishment?
Copy 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:

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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?

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Section: Product Data
Product and Model Identification
Note:

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
What product type is being reported? *Please note that this list of 66 product types are grouped according to their radiation
type and applicable regulations (e.g., laser products, microwave products, ionizing products, etc.)

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What is the product code?

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If you know the three letter code, enter it in the space provided.
If you do not,
- Click the filter search icon (next to the trash can). You will see a product code filter dialog box.
-Enter a keyword to search the database. You will be provided a list of product codes from which to choose.
(If you are not finding the correct product, try other words and/or variations of the keywords.)
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
- If you do not find the code that you are looking for, use RZZ (Other)
Product Code
Device Class
Classification Panel
C.F.R. Section
If Other, please identify the specific product type.

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the
Product Type Reported section?

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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?
Provide the Accession Number of the report for which this is a supplement (Do not enter any Device
Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs, etc.):
Are you requesting a new variance, a renewal, extension or amendment to a previous variance?
If you are requesting a renewal, extension, or amendment, please provide the variance number that

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was issued by CDRH.

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

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Provide an explanation:

Responses to Noncompliances or Defects
Does this documentor any of its attachments contain:
A refutation of noncompliances?

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A request for an exemption from notification and corrective action?

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Information on corrective actions you may be conducting?

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A description of any design changes for future production?

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Provide an explanation:

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

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

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

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Request for approval of alternate labeling?

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Application for alternate test procedures (1010.13)?

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Provide an explanation:

Attach any necessary files.

File Attachment

Variance Requests
Message:

Click the "Add" button to select the desired requirement from which you are seeking a variance.

This submission includes an application for a variance from certain requirements.
Item

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Provide an explanation and attach supporting files, if necessary. Click on the Add... button below to attach files.
Details
File Attachment
Error:

In addition to the electronic copy of this submission, please be sure to submit one hard-copy of the signed
variance request document to the following address:
Division of Dockets Management (HFA-305)
Food and Drug Administration
Rm 1061, 5630 Fishers Lane
Rockville, MD 20852

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

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What was the date of the inspection?
A response to a warning letter from the Food and Drug Administration (FDA)?

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What was the date of the Warning Letter?
A response to a report review inquiry from the Center for Devices and Radiological Health (CDRH) (the
inquiry may have been in the form of a letter, email, or phone call)?

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What was the date of the inquiry?
A response to any other communication from FDA?
What was the date of the communication?
Provide an explanation:

Use Environment
Who are the intended users?
[
[
[
[
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff
] Patients
] Other

What is the use environment?
[
[
[
[
[
[
[
[
[
[

] Consumer Home
] Hospital or Clinic
] Industrial Facility or Factory
] Office/Warehouse/Store
] Outdoors
] Public Arena
] Schools, Gymnasium/Auditorium
] Lab or Research Facility
] Transportation Facility
] Other

Please select the best match for the affected population:
[ ] Children and/or Youth
[ ] Consumers

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[
[
[
[
[
[
[

] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff
] Patients
] Other

Additional Information
Is there any other relevant information or additional comments that would help expedite the review of this submission? Click the
Add... button below to attach any supporting files.
File Attachment
Details

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

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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.

If it has not been assigned yet, provide an explanation and submit it as soon as you receive such a filing number.

Electromagnetic Compatibility and Interference
Note:

Electromagnetic Compatability (EMC) and Electromagnetic Interference (EMI) description: This question
concerns the evaluation of your product's susceptibility to EMI and/or freedom from causing EMI.For additional
information on EMC and EMI please refer to the FDA website at: http://www.fda.gov/cdrh/emc/emc-in-hcf.html

Electromagnetic Compatibility with other Products
Provide description of analysis and indicate any shielding you have for your product to protect other products from EMI:

Susceptibility to EMI from other Products
Provide description of analysis and indicate any protective shielding your product has to protect it from EMI:

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.
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.
2.2 Approval of Alternate Means

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)?

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What requirement are you requesting an approval of alternate means from?

Provide an explanation:

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
Is it a product that is intended to be used with a laser?

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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
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.

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?

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

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

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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)?

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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

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.

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Describe the external and internal laser radiation fields and paths:

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File Attachment

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:

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Do these procedures provide human access to ANY laser or collateral radiation?

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

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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:

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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:

Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI?

*
*

Indicate those collateral and laser radiation fields to which human access is possible during those maintenance procedures:

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:

Do these procedures provide human access to laser or collateral radiation levels in excess of Class I or Table VI?

*
*

Indicate those collateral and laser radiation fields to which human access is possible during those service procedures:

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?

*

4.2 Certification Label
Note:

Required on all laser products.

Is a certification label present on your product?

*

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?
Attach a copy of the certification label with an indication of its location on the product:

*

File Attachment

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:

File Attachment

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

*

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

*

4.6 Operation
Note:

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

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

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)?

*

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

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

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

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:

4.8.3 Basis of Reported Values

The values reported for the laser product are based on:
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

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:

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

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:

*

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:

*

File Attachment

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:

File Attachment
Describe how the protective housing prevents access to unnecessary collateral radiation in excess of Table VI:

File Attachment

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:
Maintenance:
Service:
Does your laser product incorporate any safety interlocks?
What types of interlocks (select all that apply):
Item
If other, then please specify:
Provide an electrical block diagram illustrating the logic of all interlock systems:

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

File Attachment

5.2.1 Safety Interlock Types
What type of safety interlock is this?

Is this optional?

Non-Defeatable Safety Interlocks

With which laser product performance standard does this type comply?

Select how this type operates:
If other, please explain how it operates:

Is this type designed to allow defeat?

*

Actuated during:
Item

To what radiation level does this type prevent access?

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?

Describe the means of providing a visible or audible indication of defeat:

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):

Describe the possible modes of failure of each safety interlock and the resultant effect upon the radiation safety of the laser
product:

State the rating of each safety interlock, including the number of operational cycles before failure:

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?

*

Describe the electrical and mechanical construction and operation of the remote connector (give its circuit and physical location):

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?

*

What type of security control is it?
If other, then please specify:
Describe how it works,including how the key control prevents unauthorized use of the product:

Is the key control removable in the "On" position?
Describe the function of the key control and how it renders the laser inoperable when the "key" is removed:

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?

*

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:

What type of emission indicator is incorporated?
If "other", please describe:

How is your emission indicator warning fail-safe or redundant?

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?

*

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

*

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?
How is emission delay achieved?
If other, then please explain further:
Please provide additional information, as needed:

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?
Is protective eyewear recommended?
Can all visible emission indicators be seen through eyewear?

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?

*

Does your product have an alternative?
Describe or attach request for approval of alternate means:

File Attachment

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?

*

Describe:

File Attachment

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:

*

If so, please further describe the viewing optic that is incorporated:

File Attachment
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?
Provide calculations and/or measurements,including pertinent attenuation factors, window transmission characteristics, etc.:

File Attachment

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

File Attachment
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):

File Attachment
Whenever the shutter is opened or the attenuator is varied:

File Attachment

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?

*

Describe the mechanical, electrical, and functional characteristics of any required scan failure safeguard:

File Attachment
Is the classification of the product based on the level of scanned radiation?
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:

File Attachment

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?
Provide the circuit and physical description and location of the manual reset mechanism:

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

*

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

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:

File Attachment

5.11.1 Laser Radiation Levels
Is the radiation level continuously monitored?
Explain how the radiation level is monitored:

Describe how the system can assure the accuracy of the displayed value to within 20%:
File Attachment

5.11.2 Measurement and Monitoring Uncertainties
Specify the uncertainty in the measurement system and describe the method by which it was derived:

File Attachment
Specify the uncertainty in the monitoring system and describe the method by which it was derived:

Describe how the displayed power/energy level is either measured at the point of delivery or measured earlier and then the actual
output calculated:

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%:

File Attachment

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

File Attachment

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?

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?
Is a variance application for a laser light show projector and laser light show being submitted along
with this report?
Does its user instructions include a warning not to direct the laser radiation at the audience?

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:

*

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:

File Attachment

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.

*

File Attachment

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:

File Attachment

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:

File Attachment

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?

Does your product have any noninterlocked protective housing labels?
Attach a copy with an indication of its location on the product:

File Attachment
Indicate how the label(s) are visible both prior to and during opening or removal of housing:

Does your product have any defeatably interlocked protective housing labels?
Attach a copy with an indication of its location on the product:

File Attachment
Indicate how the label(s) are visible both prior to and during interlock defeat:

Does your product have any optionally interlocked protective housing labels?

*

Attach a copy with an indication of its location on the product:

File Attachment
Indicate how the labels are visible both prior to and during opening or removal of the housing:

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]:

*

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

*

Does it contain clear warnings to avoid exposure?

*

Does it contain a statement of output parameters?

*

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

*

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

*

Does it contain a schedule of maintenance?

*

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

*

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

*

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

*

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?

*

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:

File Attachment
Note:

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):

*

File Attachment

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):

*

File Attachment

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:

*

File Attachment
Acceptance of electrical and electronic components:

*

File Attachment
Dimensional stability and rigidity of mechanical parts and assemblies such as housings and mounts:

*

File Attachment
Environmental stability of components such as filter materials, coatings,and adhesives:

File Attachment

*

Other factors that might affect your product's radiation safety:

File Attachment
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.):

File Attachment

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:

File Attachment
Manufacturing and assembly control procedures:

File Attachment
Inspection and test control procedures:

File Attachment
Assembly and test traveler forms:

File Attachment
Inspection and test reports and checklists:

File Attachment
Other(s), specify:

*

File Attachment

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:

File Attachment

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?
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.

File Attachment
Describe those tests and controls used to determine whether the reported product is producedto be in compliance with the
Federal laser product performance standard:

File Attachment
Do you conduct in-house compliance testing for your product?
Do you have testing done by an outside contractor?

*

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:

*

File Attachment
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.

*

File Attachment

Indicate how the measurement system collects or accounts for the total radiant energy or power specified in Section
1040.10(e):

File Attachment

*

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.):

File Attachment

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]:

File Attachment
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Form FDA 3632 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (03/06)