GUIDE FOR PREPARING PRODUCT REPORTS

FOR LASERS AND PRODUCTS CONTAINING LASERS

September 1995

(Address corrections Aug. 2008)

U.S. Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Devices and Radiological Health

Rockville, Maryland 20857

FOREWORD

This guide was developed by the Office of Compliance, Center for Devices
and Radiological Health (CDRH), to assist electronic product
manufacturers in providing adequate reporting of radiation safety
testing and compliance with performance standards. Reporting
requirements are specified in Title 21 of the Code of Federal
Regulations (CFR), Part 1002.

Reports submitted on radiation safety of electronic products must follow
the appropriate guide (21 CFR 1002.7), or contain a justification why it
was not followed. CDRH may reject an incomplete report and return it for
completion. When the report is adequate for filing, it will be logged
into the CDRH computer system and assigned an accession number. The
submitter of the report will receive an acknowledgment letter with the
accession number we assign 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.

WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is
the manufacturer\'s responsibility to certify that their products comply
with the applicable standard (21 CFR 1010 - 1050), based on a testing
program in accordance with good manufacturing practices. The
manufacturer is required to submit the report (21 CFR 1002) and to
comply with all applicable importation requirements (21 CFR 1005) prior
to the shipment of products in interstate commerce. If there are
deficiencies, we may disapprove the firm\'s quality control and testing
program or determine that the product contains a radiation defect or
fails to comply with a standard. We will notify the manufacturer if we
make such a determination. Then the manufacturer may be required to
cease introduction into U.S. commerce until deficiencies are corrected,
and to initiate a corrective action program (21 CFR 1003 - 1004) for
products already introduced into commerce.

We are making our reporting guides available on the CDRH web site at
http://www.fda.gov/cdrh/comp/eprc.html, for downloading and
reproduction. They are not copyrighted and may be reproduced as needed.

Please mail your reports to the address below (electronic submissions
cannot be processed yet). Provide one original IN ENGLISH (no facsimile,
please) unless specified otherwise in the guide. Make a copy of the
completed report for your records. If you would like to comment on the
reporting guides or the electronic docket or future electronic
submissions, you may direct the comments to the same

address. If you need additional regulations for electronic products or
medical devices, contact the Division of Small Manufacturers,
International, and Consumer Assistance by telephone at 1-800-638-2041 or
301-443-6597, or by facsimile at 301-443-8818.

Sincerely yours,

![](media/image1.png){width="2.4569444444444444in"
height="0.6263888888888889in"}

Lillian J. Gill

Director

Office of Compliance

MAILING ADDRESS:

Center for Devices and Radiological Health

Attn: Electronic Product Reports

Electronic Product Document Control (HFZ-309)

Office of Communication, Education, and Radiation Programs

9200 Corporate Blvd.

Rockville MD 20850

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

PREFACE

Manufacturers of products subject to performance standards under the
Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C -
Electronic Product Radiation Control are required to furnish various
reports to the Center for Devices and Radiological Health (CDRH). This
guide is for use by manufacturers of lasers and products containing
lasers in preparing Product Reports as required by paragraph 1002.10 and
1002.11 of Title 21 CFR (Code of Federal Regulations).

This reporting guide incorporates all current changes and should be used
in conjunction with the companion publication, \"Compliance Guide for
Laser Products.\" You should read and understand that guide and
determine how your product complies with the regulations before
completing this report. To further assist you, relevant Sections of
Title 21 CFR are cited in parentheses throughout this guide.

If you have specific questions, write to the Electronic Products Branch,
Office of Communication, Education and Radiation Programs, Center for
Devices and Radiological Health, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, or call (240) 276-3332.

I. Paul Leggett, Chief

Electronic Products Branch

Division of Enforcement III

Office of Compliance

CONTENTS

Page

FOREWORD i

PREFACE ii

GENERAL INSTRUCTIONS iv

DEFINITIONS vi

PART 1: MANUFACTURER AND REPORT IDENTIFICATION 1

PART 2: PRODUCT AND MODEL IDENTIFICATION 2

PART 3: COMPLIANCE WITH THE LABELING REQUIREMENTS 4

PART 4: COMPLIANCE WITH THE INFORMATIONAL REQUIREMENTS 6

PART 5: DESCRIPTION OF THE PRODUCT 7

PART 6: LEVELS OF ACCESSIBLE LASER RADIATION AND

CLASSIFICATION OF THE LASER PRODUCT 9

PART 7: COMPLIANCE WITH THE PERFORMANCE REQUIREMENTS 11

PART 8: QUALITY CONTROL TESTS AND TESTING PROCEDURES 21

PART 9: LIFE AND ENDURANCE TESTING 22

PART 10: INSTRUMENTATION AND CALIBRATION 24

GENERAL INSTRUCTIONS

Product Reports, Supplemental Reports, and Abbreviated Reports must be
submitted to the Center for Devices and Radiological Health (CDRH) at
the address on the following page prior to introduction of the reported
products into commerce. (This includes products imported into the U.S.)

This guide should be followed for all lasers and products containing,
incorporating, or intended to incorporate, a laser or laser system \[see
the definition of \"laser product\" in section 21 CFR 1040.10(b)(21)\].
A separate guide for reporting additional information concerning laser
light shows is being published concurrently with this guide and must be
used in conjunction with this guide when appropriate (Reporting Guide
for Laser Light Shows and Displays).

A complete Product Report is required for each laser product model or
model family. Product Reports were formerly called Initial or Model
Change Reports. Since these reports contain essentially the same
information, the single term, Product Report, is now used. 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
guide where there are differences to report, referencing the number of
the affected item. Items that are unchanged need only be referenced to
the original report.

A new or modified model belonging to a previously reported model family
must be reported in a Supplemental Report on that model family prior to
its introduction into commerce.

If an individual item or requirement of the standard is not appropriate
for the laser product, so indicate. In general, any aspect of the
product that pertains to radiation safety should be reported, including
aspects not covered by the guide, such as special use conditions; other
controls, indicators or warnings; and aspects for which there are no
applicable provisions in sections 1040.10 and 1040.11.

Much of the information requested in this guide can be given in the
space provided. Where attachments are required, so indicate in the space
provided in the body of the guide. Attachments should be clearly
numbered the same as the specific part of the guide to which they are
addressed. For example, an attachment responding to Part 3.2 should be
labeled \"Attachment 3.2.\"

The report for each laser product model family should be complete and
separable from the reports for other model families. However, certain
information to be reported may be the same for two or more model
families, such as quality control and testing programs, instrumentation,
and calibration procedures. Such information may be fully reported in
one model family report and ref­erenced in another. If this is done, the
reference must be clear and un­ambiguous, including the CDRH accession
number, date, and item number.

The manufacturer must be sure that referenced information is accurate,
current, and ap­plicable to the reported models. Information that is
applicable to more than one model family, but cannot be referenced in
accordance with the above guidance, should be duplicated and included in
each report.

When new models of a laser 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 should be clearly
marked as such and be submitted prior to October 1, December 1, March 1,
and/or June 1 when required. \[See 21 CFR 1002.13(c).\]

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).

All reports and correspondence must be addressed to:

Center for Devices and Radiological Health

ATTN: Electronic Product Reports

Electronic Product Document Control (HFZ-309)

9200 Corporate Blvd.

Rockville, MD 20850

When a report is received at CDRH, a unique accession number will be
assigned for future reference. The submitter will be informed of the
accession number in a letter of acknowledgment, which should not be
construed as a technical review of the report. The report will be
reviewed by CDRH technical staff as soon as possible and the submitter
will be advised of the results. Clearly identify Supplemental Reports
with the accession number of the relevant Product Report.

The Product Reporting Guides and Annual Reporting Guides are available
from the Division of Small Manufacturers, International, and Consumer
Assistance (DSMICA) in Rockville, Maryland at 1-800-638-2041. DSMICA
should be contacted for requests of any current documents, including
information on medical device approval procedures, registration &
listing of medical devices, and the reporting guides mentioned here. If
you have specific questions regarding regulations or filling out these
reports, call the Electronic Products Branch at (240) 276-3332.

DEFINITIONS

NOTE: These definitions have been revised.

PRODUCT REPORT (21 CFR 1002.10) - A Product Report is a report submitted
by a manufacturer of a regulated product, e.g., laser products,
sunlamps, TV. The Product Report describes the product, details how the
product complies with the standard, and explains the quality control
program to assure compliance. A Product Report can be used for families
of products as well as for individual products.

SUPPLEMENTAL REPORT (21 CFR 1002.11) - A Supplemental Report provides
information supplementary to a previously submitted Product Report. It
is used to report a new model in a previously reported model family, a
modification of a previously reported model, or other changes to a
previous report (e.g., changes in testing programs, additions or changes
in user or service manuals, responses to CDRH report review letters).

Supplemental Reports are also required for changes that:

a.affect actual or potential radiation emission,

b.affect the manner of compliance with a standard or affect the manner
of testing for radiation safety.

Supplemental Reports should clearly reference the CDRH accession number
of the Product Report and the appropriate sections of this guide.

ANNUAL REPORT (21 CFR 1002.13) - An Annual Report summarizing the
required records must be submitted by September 1 for the 12 months
ending on June 30 of the same year. In addition, the Annual Report is
the appropriate vehicle for identifying new models for which
Supplemental Reports are not required. If the new models do not involve
changes in radiation emission or performance requirements, then the
manufacturer need only identify them in their annual report, or in
quarterly updates to the annual report. Copies of the annual report form
to be followed are available from DSMA by calling 1-800-638-2041.

MODEL FAMILY - A model family is a group of two or more laser product
models with basically similar design, performance features and intended
function, manufactured under the same or very similar quality control
and testing procedures. Models within the same family may have different
outputs and different laser media and, in some cases, may belong to
different classes.

Applicability of reporting and recordkeeping requirements for laser
products:

Class I, IIa, II, and IIIa lasers and laser products containing such
lasers will require: Product Report, Annual Report, test records, and
(for all except Class I lasers) manufacturer\'s distribution records.

Note that for these classes 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, and products containing such lasers,
require all of the above plus Supplemental Reports when the criteria
requiring submission of Supplemental Reports are met.

LASER PRODUCT REPORT

PART 1: MANUFACTURER AND REPORT IDENTIFICATION

1.1 Manufacturer:

Manufacturing Firm:

Address:

Corresponding official:

Signature:

Name & title:

Telephone number:

Firm\'s Prime Contact or Responsible Person if different from above:

Name & title:

Telephone number:

1.2Importing agent (For manufacturers exporting to the U.S.,

see 21 CFR 1005.25.):

Signature:

(Or attach copy of written agreement with agent)

Name & title:

Address:

Telephone number:

1.3 Report type: (   ) Laser Product Report, or

(   ) Supplement to CDRH Accession No.:

submitted on (date):

1.4 Date of this report:

PART 2: PRODUCT AND MODEL IDENTIFICATION

2.1List all names, brand names, model numbers and model family
designations of the laser product being reported. If the product is sold
by other companies under different brand names, also give the names and
addresses of the companies, the brand names, and the model numbers, and
indicate how the brand names and model numbers correspond with your own
brand names and model numbers.

2.2Is your laser product the result of the modification of a laser
product certified by another manufacturer? \[see 1040.10(i)\]

( ) Yes ( ) No

If yes, identify the manufacturer(s), brand(s), and model number(s).

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).

2.3Does your laser product incorporate an unmodified, certified laser
product?

( ) Yes ( ) No

If yes, identify the manufacturer(s), brand(s), and model number(s).

2.4Does your product incorporate a noncertified laser product?

( ) Yes ( ) No

If yes, identify the manufacturer(s), brand(s), model(s), and describe
the type of product.

2.5Does your laser product incorporate a removable laser system or
systems as defined in 1040.10(c)(2)?

( ) Yes ( ) No

If yes, identify the manufacturer(s), brand(s), and model number(s).

2.6If the laser product, as introduced into commerce, is not supplied
with a laser or laser system or the product does not incorporate a laser
or laser system, report by manufacturer and model number which laser or
laser system, if any, is recommended by you for use with the product.

2.7If 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 to be incorporated.

PART 3: COMPLIANCE WITH THE LABELING REQUIREMENTS

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 all required labels in your
response to this Part or to Part 5. Reference to diagrams, photographs,
blueprints, product literature, etc., is acceptable. See Compliance
Guide, page 7, for assistance.

3.1Certification label - Required on all laser products (1010.2).

Is the label (or a copy) submitted with this report?

( ) Yes ( ) No

Location on product:

3.2Identification label - Required on all laser products (1010.3).

Is the label (or a copy) submitted with this report?

( ) Yes ( ) No

Location on product:

3.3Warning logotype - Required on Class II, III, and IV laser products.
\[1040.10(g)(1), (2),(3),(4),(8),(9),(10)\].

Is the label (or a copy) submitted with this report?

( ) Yes ( ) No

Location on product:

3.4Warning label - Required on Class IIa laser products
\[1040.10(g)(1)(i)\].

Is the label (or a copy) submitted with this report?

( ) Yes ( ) No

Location on product:

3.5Aperture label(s) - Required on Class II, III and IV laser products
\[1040.10(g)(5),(8),(9),(10) or 1040.11(a)(3)\].

Are the label(s) (or copies) submitted with this report?

( ) Yes ( ) No

Location on product:

3.6Label(s) for noninterlocked protective housings
\[1040.10(g)(6),(8),(9),(10)\].

Are the label(s) (or copies) submitted with this report?

( ) Yes ( ) No

Location on product:

Are the label(s) visible both prior to and during opening or removal of
housing? ( ) Yes ( ) No

3.7Label(s) for defeatably interlocked protective housings
\[1040.10(g)(7),(8),(9),(10)\].

Are the label(s) (or copies) submitted with this report?

( ) Yes ( ) No

Location on product:

Are the label(s) visible both prior to and during interlock defeat? ( )
Yes ( ) No

3.8Label(s) for optionally interlocked protective housings. (See Laser
Notice of March 2, 1977, dealing with optional interlocks.)

Is the label (or a copy) submitted with this report?

( ) Yes ( ) No

Location on product:

Are labels visible both prior to and during opening or removal of the
housing? ( ) Yes ( ) No

NOTE: IF THE LABELING REQUIREMENTS ARE INAPPROPRIATE TO YOUR PRODUCT,
YOU MAY APPLY FOR APPROVAL OF ALTERNATE LABELING. See sections 1010.2,
1010.3, and 1040.10(g)(10).

PART 4: COMPLIANCE WITH THE INFORMATIONAL REQUIREMENTS

4.1Submit copies of user and servicing information (operator and service
manuals) for your laser product. If the manuals are very extensive,
submit those portions that confirm compliance with Section 1040.10(h)
\[and 1040.11(a)(2), if a medical laser product\] and that permit
understanding how your laser product functions. See Compliance Guide,
page 8, for assistance.

Are copies of user and service information attached to this report?

(   ) Yes   (   ) No

If \"Yes,\" please identify attachment:

If \"No,\" explain why:

NOTE: THESE MATERIALS MAY ALSO BE USED IN THE PRODUCT DESCRIPTION
required by Part 5.

4.2Submit copies of any catalogs, specification sheets, and descriptive
brochures for Class IIa, II, III, and IV laser products.

Are copies of catalogs, specification sheets, or brochures attached to
this report?

(   ) Yes   (  ) No

If \"Yes,\" please identify attachment:

If \"No,\" explain why:

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.

PART 5: DESCRIPTION OF THE PRODUCT

5.1Describe the product and its function. You may refer to brochures and
manuals submitted with this report. Please include drawings or
photographs adequate to document compliance of the product with the
performance and labeling requirements.

Is a product description attached to this report?

( ) Yes ( ) No

Please identify attachment:

5.2Describe the external and internal laser radiation fields and paths.
Beam path diagrams indicating protective housing, beam attenuators,
viewports, scanners, targets, etc. would be helpful. Please identify
external and internal laser power or energy levels where applicable.

Are description and diagrams of the laser radiation fields and paths
attached?

( ) Yes ( ) No

Please identify attachment:

5.3List the procedures performed during OPERATION and indicate those
collateral and laser radiation fields specified in Part 6 to which human
access is possible when those procedures are being performed. \[See
definition of human access - Section 1040.10(b)(15)\].

Operational procedures and accessible radiation:

5.4List the procedures performed during MAINTENANCE and indicate those
collateral and laser radiation fields specified in Part 6 to which human
access is possible when those procedures are being performed. See the
definition of maintenance in section 1040.10(b)(24) and Compliance
Guide, page 5.

Maintenance procedures and accessible radiation:

5.5List the procedures performed during SERVICE and indicate those
collateral and laser radiation fields specified in Part 6 to which human
access is possible when those procedures are being performed.

Service procedures and accessible radiation:

PART 6: LEVELS OF ACCESSIBLE LASER RADIATION AND

CLASSIFICATION OF THE LASER PRODUCT

6.1Give the specifications of all laser radiation fields described in
Part 5 to which human access is possible during OPERATION. See Section
1040.10(e) for measurement parameters. Indicate whether the values are
measured or based on calculations. Whether measured or calculated,
please provide a diagram of your measurement/calculation set-up, and
pertinent dimensions such as separation distances, source and detector
aperture size, etc. in order to show how your measurements or
calculations are in accordance with 1040.10(e).

Please provide as much of the following as is appropriate to your
product:

wavelength(s): nm

maximum average radiant power: W

beam divergence: degrees/radians

beam diameter at laser aperture: mm

IF PULSED: pulse energy: J

peak power: W

pulse duration: sec

repetition rate:

IF APPLICABLE:

maximum irradiance or radiant exposure: W or J cm-2

max. radiance or integrated radiance: W or J cm-2 sr-1

Are measurement parameters, diagrams, calculations, and/or
specifications submitted as an attachment to this report?

( ) Yes - Please identify attachment:

( ) No

6.2Indicate the Class of the laser product, based on your response to
Part 6.1.

(    ) Class I (    ) Class IIa (    ) Class II

(    ) Class IIIa (    ) Class IIIb (    ) Class IV

6.3Give the specifications of all possible laser radiation fields
described in Part 5 to which human access is possible during
MAINTENANCE.

Are specifications attached? ( ) Yes ( ) No

6.4Give the specifications of all possible laser radiation fields
described in Part 5 to which human access is possible during SERVICE.

Are specifications attached? ( ) Yes ( ) No

6.5Describe all collateral radiation associated with the product. Report
the source(s) and levels and describe where and under what circumstances
such radiation is accessible.

Is description attached? ( ) Yes ( ) No

PART 7: COMPLIANCE WITH THE PERFORMANCE REQUIREMENTS

7.1Protective housing - Required for all laser products
\[1040.10(f)(1)\]

7.1.1Describe the product\'s protective housing and how it serves to
prevent unnecessary human access to laser radiation.

Is additional information attached? ( ) Yes ( ) No

7.1.2Describe how the protective housing prevents access to unnecessary
collateral radiation.

Is additional information attached? ( ) Yes ( ) No

7.2Safety interlocks - Applicable for all laser products
\[1040.10(f)(2)(i)\]

7.2.1Provide a detailed mechanical diagram showing the location of each
interlock incorporated into the laser product for radiation safety.

Is a mechanical diagram attached? ( )Yes ( )No

Describe each interlock and explain how each such interlock prevents
access to laser and/or collateral radiation when each portion of the
protective housing is opened.

Is additional information attached? ( ) Yes ( ) No

7.2.2Provide an electrical block diagram illustrating the logic of the
interlock system.

Is an electrical diagram attached? ( ) Yes ( ) No

7.2.3For each safety interlock, state whether actuation is intended
during operation, maintenance, service, or any combination thereof.

Is additional information attached? ( ) Yes ( ) No

7.2.4For each safety interlock, state the highest level of laser
radiation and collateral radiation to which access is prevented.

7.3Defeatable safety interlocks - Applicable to all laser products
\[1040.10(f)(2)(ii) and (iii)\]

7.3.1Identify which safety interlocks are designed to allow defeat and
describe how they operate.

Is additional description attached? ( ) Yes ( ) No

7.3.2For each safety interlock designed to allow defeat, state whether
defeat is intended during operation, maintenance, service, or any
combination thereof.

7.3.3For each safety interlock designed to allow defeat, describe how
replacement of a removed or displaced portion of the protective housing
is not possible while the safety interlocks are defeated.

7.3.4For each safety interlock designed to allow defeat, describe the
means of providing a visible or audible indication of defeat.

7.4Safety interlock failure - Applicable to all required safety
interlocks \[1040.10(f)(2)(iii)\] that prevent access to Class IIIb or
IV levels of laser radiation.

7.4.1Describe 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.

Are electrical/mechanical diagrams or additional information attached?

( ) Yes ( )No

7.4.2Describe the possible modes of failure of each safety interlock and
the resultant effect upon the radiation safety of the laser product.

Is additional information attached? ( ) Yes ( ) No

7.4.3State the rating of each safety interlock, including the number of
operational cycles before failure.

7.5Remote interlock connector - Applicable to Class IIIb or IV laser
systems \[1040.10(f)(3)\]

7.5.1Describe the electrical and mechanical construction and operation
of the remote interlock connector. Give its circuit and physical
location.

Are electrical/mechanical diagrams or additional information attached? (
) Yes ( ) No

7.5.2Record the open-circuit electrical potential dif­ference between the
terminals of the remote interlock connector.

Volts

7.6Key control - Required for Class IIIb or IV laser systems
\[1040.10(f)(4)\]

7.6.1Describe the electrical and mechanical construction of the
key-actuated master control.

Are electrical/mechanical diagrams or additional information attached? (
) Yes ( ) No

7.6.2Describe the function of the key-actuated master control and how it
renders the laser inoperable when the key is removed.

Are electrical/mechanical diagrams or additional information attached? (
) Yes ( ) No

7.6.3Is the key removable in the \"On\" position?

( ) Yes ( ) No

7.7Laser radiation emission indicator - Required for Class II, IIIa,
IIIb, or IV laser systems \[1040.10(f)(5)\]

7.7.1Describe in detail the mechanical and electrical characteristics of
all emission indicators installed pursuant to Section 1040.10(f)(5)(i)
or (ii) and give their locations. Note that if the energy source and
remote controller(s) are separable by more than 2 meters, then each
control must have an emission indicator.

Are electrical/mechanical diagrams or additional information attached? (
) Yes ( ) No

7.7.2Record the length of time each emission indicator of Class IIIb and
IV laser systems is actuated prior to the emission of accessible laser
radiation.

Emission indicator delay: sec

7.8Protective eyewear - Applicable to Class II, IIIa, IIIb or IV laser
systems \[1040.10(f)(5)(iv)\]

State whether protective eyewear is supplied or recom­mended for use with
the laser system. If so, confirm that any visible emission indicator can
be clearly seen through the protective eyewear.

Is protective eyewear supplied? (   ) Yes   (   ) No

Is it recommended? (   ) Yes  (   ) No

Can visible emission indicators be seen through eyewear?

( ) Yes ( ) No

7.9Beam attenuator - Required for Class II, IIIa, IIIb or IV laser
systems \[1040.10(f)(6)\]

7.9.1For each beam attenuator, describe the mechanical and electrical
characteristics and how, when actuated, the attenuator prevents 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.

Are electrical/mechanical diagrams or additional information attached? (
) Yes ( ) No

7.9.2Describe the permanency of attachment of each beam attenuator.

NOTE: YOU MAY APPLY FOR APPROVAL OF ALTERNATE MEANS of providing this
protection if a beam attenuator is inappropriate to the product.

7.10Location of controls - Applicable to Class II, IIIa, IIIb or IV
laser products \[1040.10(f)(7)\]

Explain how the location of each of the operation and adjustment
controls of the laser product is such that human exposure to laser or
collateral radiation in excess of the accessible emission limits of
Class I and Table VI is prevented during operation or adjustment of such
controls.

7.11Viewing optics - Applicable to all laser products \[1040.10(f)(8)\]

7.11.1State whether all laser and collateral radiation accessible by
virtue of viewing optics, viewports, and display screens incorporated
into the reported model of laser product is less than the accessible
emission limits of Class I and Table VI during operation and
maintenance. Include with your calculations pertinent attenuation
factors, window transmission characteristics, etc.

Are electrical/mechanical diagrams or additional information attached? (
) Yes ( ) No

REMINDER: Report in Part 5 the location and identification of laser and
collateral radiation made accessible by viewing optics, viewports, and
display screens. In Part 6, report the highest levels.

7.11.2Describe 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. Describe
how exposure of the eye to laser or collateral radiation in excess of
the accessible emission limits of Class I and Table VI is prevented
whenever the shutter is opened or the attenuator is varied.

Are diagrams/photographs or additional information attached?

( ) Yes ( ) No

7.11.3Describe how exposure of the eye to laser or collateral radiation
in excess of the accessible emission limits of Class I and Table VI is
prevented in the event of failure of the shutter or variable attenuator,
as required by Section 1040.10(f)(8)(ii).

Are diagrams or additional information attached?

( ) Yes ( ) No

7.12Scanning safeguard - Required for certain laser products with
scanned laser radiation \[1040.10(f)(9)\].

Describe the mechanical, electrical, and functional characteristics of
any required scan failure safeguard. Include calculations to show that
the safeguard\'s reaction time is adequate for compliance with this
section.

Are electrical/mechanical diagrams, calculations, or additional
information attached?

( ) Yes ( ) No

NOTE: A SAFEGUARD IS REQUIRED WHEN SCAN FAILURE WOULD CAUSE THE PRODUCT
TO EXCEED THE EMISSION LIMITS OF THE CLASS OF THE PRODUCT, OR in the
case of Class IIIb or IV laser products WOULD CAUSE THE ACCESSIBLE
EMISSION LIMITS OF Class IIIa TO BE EXCEEDED.

7.13Manual reset - Applicable to Class IV laser systems manufactured
after August 20, 1986.

Provide the circuit and physical description and location of the means
provided to require manual restart following interruption of emission
caused by power failure of at least 5 seconds or deactivation through
the remote interlock connector.

7.14Medical laser product - Applicable to Class III or IV medical laser
products intended for in-vivo surgical, therapeutic, or diagnostic
irradiation of the human body.

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.

If your product is a Class III or IV medical laser product, provide the
following information:

7.14.1Describe 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.

Are electrical/mechanical diagrams, calculations, or additional
information attached?

( ) Yes ( ) No

7.14.2Specify the uncertainty in the measurement system and describe the
method by which it was derived.

Are calculations or additional information attached?

( ) Yes ( ) No

7.14.3Is the displayed power/energy level measured at the point of
delivery or earlier and then calculated? If the displayed level is
calculated incorporating system constants, losses, attenuation factors,
etc. please provide calculations to demonstrate accurate calibration of
the delivered beam to within + or - 20%, as required by 1040.11(a)(1).

Are calculations or additional information attached?

( ) Yes ( ) No

7.14.4Are procedures and a schedule for recalibration of the measurement
system included in the user instructions?

( ) Yes ( ) No

If yes, please identify location in the user instructions:

7.15Surveying, leveling, or alignment laser products - Is the product a
surveying, leveling, or alignment laser product?

( ) Yes ( ) No

If yes, then it is subject to the requirements of section 1040.11(b). 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. Procedures for applying for a variance are
given in section 1010.4, and described in the Compliance Guide, page 13.

7.16Demonstration laser products - Is the product a demonstration laser
product? ( ) Yes ( ) No

If yes, then it is subject to the requirements of section 1040.11(c). 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. Procedures for applying for a variance are
given in the Compliance Guide, pages 13 and 16-22.

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. A Laser Light Show report may also be
required if you intend to produce shows or displays with Class IIIb or
Class IV demonstration laser products. The Reporting Guide for Laser
Light Shows and Displays should be filled out and submitted along with
this report and the variance application, following the instructions in
each document.

7.16.1Is a Variance application being submitted along with this report?

( ) Yes - date of submission: ( ) No

7.16.2Is a Laser Light Show report being submitted along with this
report?

( ) Yes - date of submission: ( ) No

PART 8: QUALITY CONTROL TESTS AND TESTING PROCEDURES

8.1Attach, and identify as attachments to Part 8, 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. These may include:

( ) specification controls for critical components,

( ) manufacturing and assembly control procedures,

( ) inspection and test control procedures,

( ) assembly and test traveler forms,

( ) inspection and test reports and checklists, and/or

( ) other(s) (specify):

8.2If 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.

NOTE: 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.

PART 9: LIFE AND ENDURANCE TESTING

Describe those tests and controls used to ensure that the reported
product will remain in compliance with the Federal laser product
performance standard during its useful life. Items to be addressed
include:

9.1Dimensional stability and rigidity of mechanical parts and assemblies
such as housings and mounts

Is additional information/documentation attached?

( ) Yes ( ) No

9.2Design and ratings of electrical and electronic components

Is additional information/documentation attached?

( ) Yes ( ) No

9.3Environmental stability of components such as filter materials,
coatings, and adhesives

Is additional information/documentation attached?

( ) Yes ( ) No

9.4Design and testing of features designed to meet Federal laser product
performance requirements

Is additional information/documentation attached?

( ) Yes ( ) No

9.5Other factors that might affect your product\'s radiation safety

Is additional information/documentation attached?

( ) Yes ( ) No

NOTE: MAINTENANCE AND/OR SERVICE INSTRUCTIONS MUST INCLUDE SCHEDULES FOR
MAINTENANCE AND REPLACEMENT OF THOSE COMPONENTS RELATED TO THE
COMPLIANCE OF THE PRODUCT that may be expected to be replenished or
replaced during the life of the product.

PART 10: INSTRUMENTATION AND CALIBRATION

Describe those tests and controls used to ensure that the reported
product will remain in compliance with the Federal laser product
performance standard during its useful life. Items to be addressed
include:

10.1List 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.

Is additional information attached? ( ) Yes ( ) No

10.2Indicate how the measurement system collects or accounts for the
total radiant energy or power specified in Section 1040.10(e).

Is additional information attached? ( ) Yes ( ) No

10.3Provide a measurement error analysis (for all sources of error
identified) and an uncertainty statement for all measurement data
reported.

Is additional information attached? ( ) Yes ( ) No

NOTE: IF IT IS CLEAR 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 milliwatt HeNe laser product classified in
Class IIIa.

10.4Provide 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).

Is additional information attached? ( ) Yes ( ) No

NOTE: IF YOUR LASER PRODUCT OPERATES AT A LEVEL CLOSELY APPROACHING A
SPECIFIED LIMIT, HIGH ACCURACY AND TRACEABILITY TO THE NATIONAL
INSTITUTE OF STANDARDS AND TECHNOLOGY (previously known as the National
Bureau of Standards) ARE IMPORTANT.