On January 20, 2023, FDA issued a final rule entitled Radiological Health Regulations; 
Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments 
to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products (88 FR 3638)1. 
This final rule went into effect on February 21, 2023 and amended the records and reporting 
requirements for electronic products and medical devices by removing or reducing some of the 
annual reports and test record requirements that are unnecessary or may be duplicative of other 
reporting requirements (see 21 CFR 1002.1), among other changes. The amendments codified 
long-standing policies previously found in Low Power Laser Reporting Exemption (Laser Notice 
41) and Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate 
Certified Class I Laser Products into Their Products (Laser Notice 42).
In addition, Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 
(Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff2 revises 
certain policies within this Compliance Guide for Laser Products.
A list of additional guidance that are applicable to manufacturers of laser products may be found 
at: Electronic Product Radiation Control Program: Industry Guidance.3
FDAs website including additional information on Laser Products and Instruments4 and general 
information about Getting a Radiation Emitting Product to Market: Frequently Asked 
Questions.5
For questions about this document, contact Office of Health Technology 8 (OHT8): Office of 
Radiological Health at RadHealth@fda.hhs.gov. 
1 https://www.federalregister.gov/documents/2023/01/20/2023-00922/radiological-health-regulations-amendments-
to-records-and-reports-for-radiation-emitting-electronic 
2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-conformance-iec-
60825-1-ed-3-and-iec-60601-2-22-ed-31-laser-notice-no-56 
3 https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program/electronic-product-
radiation-control-program-industry-guidance 
4 https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-
instruments 
5 https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program/getting-radiation-
emitting-product-market-frequently-asked-questions   
  HHS Publication FDA 86-8260 
 
 
 
 
 
 
COMPLIANCE GUIDE FOR LASER PRODUCTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
June 1992 
 
(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   
  CONTENTS 
 
    Page 
 
 
INTRODUCTION ...............................................................   1 
 
DESIGN  AND  MANUFACTURE  OF  THE  LASER  PRODUCT TO  COMPLY  WITH  THE  
STANDARD .............................................................   2 
 
CLASSIFICATION  OF  LASER  PRODUCTS ........................................   3 
 
REQUIREMENTS FOR LASER PRODUCTS ............................................   7 
 
PERFORMANCE  REQUIREMENTS ..................................................   7 
 
LABELING  REQUIREMENTS .....................................................  12 
 
INFORMATIONAL  REQUIREMENTS ................................................  13 
 
REQUIREMENTS  FOR  SPECIFIC-PURPOSE  PRODUCTS ..............................  14 
 
RECORDKEEPING, REPORTING, AND NOTIFICATION .................................  15 
 
RECORDKEEPING ..............................................................  15 
 
REPORTING  AND  NOTIFICATION ...............................................  16 
 
PRODUCT  RECALLS ...........................................................  18 
 
VARIANCES AND EXEMPTIONS ...................................................  19 
 
APPENDIX A:  TABULATION  OF  FDA  REQUIREMENTS  FOR  LASER  PRODUCTS .......  21 
 
APPENDIX B:  CLARIFICATION  OF  CERTAIN  LASER  LIGHT  SHOW  REQUIREMENTS ..  22 
   
  COMPLIANCE GUIDE FOR LASER PRODUCTS 
 
 
  INTRODUCTION 
 
This guide briefly summarizes the requirements of the regulations under the 
Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - 
Electronic Product Radiation Control, that applies to manufacturers of laser 
products.  It explains the performance, labeling, and informational requirements 
of the standard and the procedures for remedial actions and for variances or 
exemptions.  It does not replace the regulations, however, and if there is any 
conflict between the guide and the regulations, the regulations must prevail.  
Throughout this guide, pertinent sections of Title 21, Code of Federal 
Regulations, Chapter I, Subchapter J, are cited in parentheses.  Please consult 
them before making design or procedural decisions.  The guide is current through 
the most recent amendments to the standard which were published in 1985.   
 
Specific questions may be directed to the Electronic Products Branch (HFZ-240), 
Office of Communication, Education, and Radiation Programs, Center for Devices 
and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-3332.  Laser Notices to Industry are issued 
periodically whenever it is determined that an issue needs further 
clarification, or when CDRH establishes a new policy regarding certain 
requirements.  These Notices can be requested from the Electronic Products 
Branch or the Division of Small Manufacturers, International, and Consumer 
Assistance (DSMICA), at 1-800-638-2041.  DSMICA should be contacted for requests 
of any current documents, reporting guides, and regulatory guidance on 
radiation-emitting products and medical devices. 
 
The following definitions are basic to the regulations: 
 
A laser is a device capable of producing or amplifying electromagnetic radiation 
in the wavelength range from 180 to 1 x 106* nanometers by the process of 
controlled stimulated emission [1040.10(b)(19)]. 
 
A laser system consists of a laser in conjunction with its power supply 
[1040.10(b)(23)]. 
 
A laser product is any device that constitutes, incorporates, or is intended to 
incorporate a laser or laser system [1040.10(b)(21)]. 
 
1
                     
*  This definition was effective August 20, 1986.  The range was      250 to 13,000 nanometers before
that date. 
 
 
Laser Compliance Guide (6/92)  Page 1  A manufacturer is any person or organization in the business of making, 
assembling, importing [1000.3(f)], or modifying laser products [1040.10(i)]. 
 
As explained in this guide, manufacturers of laser products must: 
 
design and manufacture their products to be in compliance with the standard; 
 
  (cid:129)test their products to assure compliance; 
 
  (cid:129)certify compliance of their products; 
 
  (cid:129)maintain test and distribution records and a file of correspondence 
concerning radiation safety, safety complaints, and inquiries; 
 
  (cid:129)use the published reporting guides to submit reports to CDRH, including Laser 
Product Reports describing compliance of the product design and testing 
program and Annual Reports summarizing required records; 
 
  (cid:129)report accidental radiation occurrences (i.e., possible, suspected, and known 
exposures); 
 
  (cid:129)report any radiation defects or noncompliances; and 
 
  (cid:129)recall (i.e., repair, replace, or refund the purchase price of) defective or 
noncompliant products. 
 
Manufacturers of OEM laser products (laser components for sale to manufacturers 
of laser products) are required to register and submit certain minimal 
information to CDRH, including the product name, model number, and the laser 
medium or wavelength [1040.10(a)(3)]. 
 
DESIGN  AND  MANUFACTURE  OF  THE  LASER  PRODUCT TO  COMPLY  WITH  THE  
STANDARD 
 
The laser standard applies to all laser products manufactured on or after August 
2, 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)(1)]; 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, 
following the OEM registration and listing requirements in 1040.10(a)(3). 
 
Laser Compliance Guide (6/92)  Page 2   
In designing laser products, manufacturers must first determine the level of 
laser radiation to which human access is necessary during operation 
[1040.10(b)(27)] in order for the product to perform its intended function.  
This level should be determined in terms of the nature of the product, as well 
as significant economic and design factors.  A laser radiation field is within 
human access [1040.10(b)(15)] if it can be intercepted by any part of the body, 
or if the levels are in Class IIIb or IV and can be reflected by a single flat 
surface through any opening or hole in the product.  Laser radiation to which 
human access is not necessary must be eliminated or contained within a 
protective housing [1040.10(f)(1)]. 
 
Manufacturers must then determine the Class of their products [1040.10(c)] 
according to the highest level of laser radiation accessible during operation.  
The Class of the product determines the requirements for controls, indicators, 
and warnings on the product and warnings in its literature.  The wording of any 
required warning is based on the injury-causing potential of accessible laser 
radiation.  The standard also contains additional requirements for specific-
purpose laser products.  Appendix A is a table summarizing the requirements of 
the standard. 
 
 
CLASSIFICATION  OF  LASER  PRODUCTS 
 
Laser products are classified on the basis of the highest level of laser 
radiation to which human access [1040.10(b)15)] is possible during operation 
only.  Other laser radiation fields to which human access is necessary only 
during maintenance or service do not affect the classification but may affect 
the labeling and safety interlock requirements.  Use-factor data, if available 
and adequately convincing, may be used in determining the level of laser 
emissions from a product. 
 
The standard establishes the following limits for the Classes: 
 
Class I limits [1040.10(b)(5) and 1040.10(d)(Table I)] apply to devices that 
have emissions in the ultraviolet, visible, and infrared spectra, and are limits 
below which biological hazards have not been established.  In the visible and 
near infra-red spectra there are separate Class I limits for radiant energy 
(power) and integrated radiance (radiance); both limits must be exceeded for the 
device to move from Class I. 
 
Class IIa limits [1040.10(b)(6) and 1040.10(d)(Table II-A)] apply to products 
whose visible emission does not exceed Class I limits for emission durations of 
1000 seconds or less and are not intended for viewing.  Class IIa limits 
therefore may not exceed the Class II limits.  An example of a Class IIa laser 
product might be a supermarket scanner. 
 
Laser Compliance Guide (6/92)  Page 3  Class II limits [1040.10(b)(7) and 1040.10(d)(Table II)] apply to products that 
have emissions in the visible spectrum (400 to 710 nm) for emission durations in 
excess of 0.25 second, providing that emissions for other durations and/or 
wavelengths do not exceed the Class I limits.  Class II products are considered 
a hazard for direct long-term ocular exposure. 
 
Class IIIa limits [1040.10(b)(8) and 1040.10(d)(Table III-A)] apply to products 
that have emissions in the visible spectrum and that have beams where the total 
collectable radiant power does not exceed 5 milliwatts.  Class IIIa products 
include most helium-neon lasers. 
 
Class IIIb limits [1040.10(b)(9) and 1040.10(d)(Table III-B)] apply to devices 
that emit in the ultraviolet, visible, and infrared spectra.  Class IIIb 
products include laser systems ranging from 5 to 500 milliwatts in the visible 
spectrum.  Class IIIb emission levels are ocular hazards for direct exposure 
throughout the range of the Class, and skin hazards at the higher levels of the 
Class. 
 
Class IV levels [1040.10(b)(11)] exceed the limits of Class IIIb and are a 
hazard for scattered (diffuse) reflection as well as for direct exposure. 
   
The Class limit expressions are given in Tables I, II-A, II, III-A, and III-B 
and are functions of wavelength and emission duration.  Included in the 
expressions of the limits are two factors, k  and k , dependent on wavelength and 
1 2
emission duration.  The values of k  and k  are in Tables IV and V.  The 
1 2
expressions also indicate the units of the limit: 
 
  J, the unit for radiant energy (joules); 
  J cm-2 sr-1, the unit for integrated radiance; and 
  J cm-2, the unit for radiant exposure. 
 
Specific conditions are given for the determination or measurement of these 
parameters [1040.10(e)]: 
 
Radiant energy (J) or radiant power (W) is the energy or power detected through 
a 7 mm diameter circular aperture with a solid angle of acceptance* of 10-3 
steradian with collimating optics of 5 diopters or less [1040.10(e)(3)(i)] for 
laser products intended to be used where viewing with optical instruments is 
unlikely.  Otherwise a 50 mm aperture stop must be used. 
 
__________________ 
* Solid angle of acceptance refers to that solid angle subtended by the source 
at the point of measurement.  The solid angle of acceptance is therefore 
independent of detector aperture.  A 7 mm diameter source subtends 10-3 sr 
at 20 cm, and a 0.7 mm diameter source subtends a 10-5 sr at 20 cm. 
 
Laser Compliance Guide (6/92)  Page 4  Integrated radiance (J cm-2 sr-1) or radiance (W cm-2 sr-1) is the energy or power 
detected through a 7 mm diameter circular aperture with a solid angle of 
acceptance of 10-5 steradian with collimating optics of 5 diopters or less, 
divided by that solid angle and by 0.385 cm2, the area of the aperture 
[1040.10(e)(3)(iii)]. 
 
Radiant exposure (J cm-2) is the energy detected through a 7 mm diameter circular 
aperture, divided by 0.385 cm2, the area of the aperture [1040.10(e)(3)(ii)]. 
 
Irradiance (W cm-2) is the power detected through a 7 mm diameter circular 
aperture with a solid angle of acceptance of 10-3 steradian with collimating 
optics of 5 diopters or less, divided by 0.385 cm2 [1040.10(e)(3)(ii)]. 
 
If the limit of a Class is exceeded at any emission duration, the product cannot 
be in that Class; all possible emission durations must be considered, ranging 
from single nanosecond pulses (1 x 10-9 sec) to the very long term average 
(greater than 104 seconds). 
 
Measurements to determine classification must be made with the measuring 
instrument positioned for maximum detection and with all controls on the laser 
product adjusted to achieve maximum emission [1040.10(e)(2)]. If calculations 
are used instead of measurements, all values must be justified and must 
represent a worst-case analysis. 
 
The measurement parameters for radiant energy, power, and irradiance also state 
that collimating optics must be used, if appropriate, in order to account for 
diverging laser sources.  The collimating optics must have an optical power of 5 
diopters or less (20 cm or longer focal length), as necessary to maximize 
detection.  Naturally collimated or expanded laser beams that have low 
divergence and maximum detectability without collimating optics must be measured 
so that all the energy collectable within the specified aperture stop is 
considered.  Multiple beams or diffuse sources that lie within a solid angle of 
acceptance of 10-3 sr must be included in the measurement. 
 
If the laser radiation is scanned, measurements of radiant energy and power are 
made with a 7 mm diameter2 circular aperture having a solid angle of acceptance 
of 10-3 steradian with collimating optics of 5 diopters or less [1040.10(e)(3)]. 
 If the angular rate of scanning is less than 5 radians/sec, the direction of 
the solid angle of acceptance must also track the scan. 
 
Note that products are classified according to the maximum level of laser 
radiation within human access during operation only.  Levels accessible only 
during maintenance or service do not affect the classification.  Hence, it is 
possible for Class I products to contain Class IV lasers. 
 
                     
          2After August 20, 1986, a 50 mm diameter circular aperture must be 
substituted for the 7 mm aperture in situations such as a laser 
light show where viewing with optical instruments is likely.  
 
Laser Compliance Guide (6/92)  Page 5  It is the responsibility of the manufacturer to determine whether specific 
functions are operation, maintenance, or service. In general, the following 
definitions apply. 
 
Operation [1040.10(b)(27)] consists of functions by which the product 
accomplishes its intended purpose; these may include loading work-pieces or 
documents and setting and manipulating external controls. 
 
Maintenance [1040.10(b)(24)] consists of functions performed by the user to 
assure performance; these may include cleaning and replenishment of expendables. 
 
Service [1040.10(b)(38)] usually means repair.  It may be performed by specially 
trained service personnel or by sophisticated users following instructions 
specifically indicated as service instructions.  Certain maintenance procedures 
will be considered service if they are infrequent, complex, or highly 
specialized. 
 
Collateral radiation [1040.10(b)(12)] is generally any optical, electromagnetic, 
or x radiation that is either necessary for, or occurs as a result of, the 
operation of a laser.  Collateral radiation includes x radiation produced by a 
high voltage power supply, plasma glow in a discharge tube, excitation lamp 
light or reradiation from a workpiece.  Limits for collateral optical radiation 
are the same as the Class I limits for laser radiation for 1000 seconds or less; 
limits for collateral x radiation are 0.5 milliroentgen in an hour averaged over 
an area of 10 cm2 parallel to the product surface with no dimension greater than 
5 cm [1040.10(d)(Table VI)]. 
 
If a laser product produces emissions of multiple wavelengths 
[1040.10(d)(1),(2),(3)], the levels of the emissions must be added if their 
wavelengths are within any individual wavelength range indicated in Table I, II-
A, II, III-A, or III-B; the emission levels may be considered separately if they 
lie in different wavelength ranges. 
 
 
  REQUIREMENTS FOR LASER PRODUCTS 
 
 
PERFORMANCE  REQUIREMENTS 
 
The standard specifies performance requirements according to the Class of the 
laser product and the accessible laser radiation.  Note that, where the standard 
requires a particular performance feature, the feature must be readily 
identifiable as such on the product.  Failure to properly identify required 
features may lead to difficulties in determining product compliance. 
 
The applicability of many requirements depends on whether the product is a laser 
or a laser system [1040.10(b)(19),(23)]. 
 
A protective housing [1040.10(f)(1)] is required for all laser products.  The 
protective housing must prevent human access to laser radiation in excess of the 
limits of Class I (and collateral radiation in excess of the collateral 
 
Laser Compliance Guide (6/92)  Page 6  radiation limits) at all places and times where and when such human access is 
not necessary in order for the product to accomplish its intended function.  In 
essence, this requirement means that the product must be of the lowest possible 
Class.  The manufacturer must be prepared to justify the necessity of human 
access to laser radiation greater than Class I limits.  If the purpose of the 
laser system is to generate a laser beam, the justification is self-evident.  In 
other cases, a detailed analysis may be required.  Generally, a protective 
housing must be contiguous.  The most common difficulties with protective 
housings have been human access to laser radiation through cooling vents or 
through a poor fit between sections of a protective housing.  A protective 
housing must be sturdy enough to prevent access caused by bending or warping as 
the product ages. 
 
Specific guidance for industrial workstations large enough for a person to enter 
is given in the Laser Notice to Industry # 37 (October 21, 1985).  The notice 
specifies security measures to be taken in designing the protective 
housing/interlock system in order to avoid certain hazardous conditions, such as 
someone being inside the enclosure when the equipment is operated. 
 
Safety interlocks [1040.10(f)(2)] may be required on any laser product.  They 
must prevent human access to laser or collateral radiation that exceeds the 
limits of Class I and Table VI when a protective housing is opened during 
operation or maintenance, and human access to the interior radiation is not 
always necessary during such operation or maintenance.  (Note that if the 
housing must be opened during operation and it is necessary to have access to 
the interior radiation, the level of the interior radiation must be considered 
when classifying the product, i.e., the classification is determined by the 
interior level, if it is higher than the exterior level.  If the intermittent 
access to laser radiation occurs only during a maintenance procedure, it does 
not affect the Class of the product.)  If access to the interior radiation is 
sometimes needed, the interlock may be defeatable and the housing must be so 
labeled.  Safety interlocks need not prevent access to interior radiation 
otherwise accessible only during service.  See Safety Interlock Requirements 
flow chart for clarification. 
 
 
Safety Interlock Requirements 
 
 
<Graphics here> 
 
 
Laser Compliance Guide (6/92)  Page 7   
Safety interlocks to protect from Class IIIb or IV levels must also be redundant 
or fail-safe; if fail-safe, they must either prevent opening the housing in case 
they fail or they must be incapable of failing in a mode that would permit 
access.  Defeatable safety interlocks must provide a visible or audible 
indication of defeat; further, it must not be possible to close the housing with 
the interlock remaining defeated.  A redundant or fail-safe safety interlock is 
also required if failure of a single interlock would allow access to laser 
radiation in excess of the accessible emission limits of Class II to be emitted 
directly through the opening created by removal or displacement of the 
interlocked portion of the protective housing. 
 
Snap-action spring switches are subject to short-circuit failure; they cannot 
serve as fail-safe safety interlocks.  However, such a switch could be used in 
series with a second such switch or with a solenoid-operated door latch if the 
access door would remain latched in the event of switch failure. 
 
CDRH has not objected to the use of switching elements consisting of shorting 
bars or plugs and sockets that operate by physical removal of a part of the 
electrical circuit when the housing is opened.  CDRH has also not objected to 
the use of cam- or wedge-driven switches in conjunction with a mechanical latch 
or key. 
 
A remote interlock connector [1040.10(f)(3)] is required on all Class IIIb and 
IV laser systems.  The purpose of the remote interlock connector is to permit 
the user to connect a remote barrier interlock, emergency stop switch, or 
similar device.  The circuit must be such that, when the terminals of the 
connector are open, human access to laser radiation is prevented.  The 
electrical potential across the connector terminals must not be greater than 130 
volts rms.  A shorted mating connector may be provided by the manufacturer to 
allow the product to be operated when the remote interlock connector is not 
being used. 
 
A key control [1040.10(f)(4)] is required for Class IIIb and IV laser systems in 
order for the user to prevent unauthorized operation.  The key must not be 
removable in the "on" position.  A computer password may serve as an adequate 
key control provided that the password must be reentered each time the computer 
is turned on or the laser operation sequence is begun.  
 
An emission indicator [1040.10(f)(5)] is required on Class II, IIIa, IIIb, and 
IV laser systems.  The indicator can be visible or audible.  On Class IIIb and 
IV laser systems the indication must precede emission by a length of time 
sufficient to allow users and others in the area to recognize that the product 
has been energized so they can avoid expo-sure. Depending on the action required 
and the level of laser radiation involved, the time needed can vary 
considerably; typical values are in the range of 2 to 20 seconds.  Emission 
indicators must be duplicated on lasers (heads) and operation controls if they 
are capable of being separated by greater than 2 meters. 
 
A beam attenuator [1040.10(f)(6)] is required on Class II, IIIa, IIIb, and IV 
laser systems.  The beam attenuator is a mechanical or electrical device such as 
a shutter or attenuator that blocks emission.  The beam attenuator blocks bodily 
 
Laser Compliance Guide (6/92)  Page 8  access to laser radiation above Class I limits without the need to turn off the 
laser.  The beam attenuator must be available for use at all times during 
operation.  Power switches and key controls do not satisfy the beam attenuator 
requirement.  Manufacturers may apply for approval of alternate means of 
providing this protection if a beam attenuator is inappropriate to the product. 
 
Note: If a beam attenuator would be inappropriate for your product, you may 
apply for approval of alternate means of providing the protection that a beam 
attenuator would provide. 
 
Operating controls [1040.10(f)(7)] on a Class II, IIIa, IIIb or IV laser product 
must be located such that it is not necessary for the user to be exposed while 
manipulating them. 
 
Viewing optics, viewports, or display screens [1040.10(f)(8)] may not provide 
human access to laser or collateral radiation in excess of the limits of Class I 
and Table VI during operation or maintenance.  If the viewing optics employ a 
shutter or variable attenuator, the shutter or attenuator must be fail-safe; 
that is, it must be designed such that, upon failure, it is impossible to open 
the shutter or vary the attenuation.  Viewing optics include such devices as 
viewports, windows, microscopes on welding and drilling devices, and operating 
microscopes on surgical lasers.  Attenuation may be total, or it may be partial 
as with a filter.  Acceptable designs may prevent laser operation until the 
attenuator has moved into position.  Service instructions must include 
instructions or procedures to avoid hazardous exposure through viewing optics. 
 
A scanning safeguard [1040.10(f)(9)] must prevent emission in excess of the 
limits of the class of the product.  For Class IIIb or IV laser products that 
operate in both scanned and unscanned modes, the scanning safeguard also must 
prevent emission in excess of the limits of the class of the scanned laser 
radiation (and whose failure would result in emissions exceeding Class IIIa).  
Scanned laser radiation is laser radiation that is moved in translation or by 
changing direction.  A scan failure safeguard must have a reaction time short 
enough to operate before levels of a higher Class are emitted; it is possible to 
achieve this performance by means of a high inertia scanner in conjunction with 
an electromechanical shutter. 
 
A manual reset [1040.10(f)(10)] is required on Class IV laser  systems 
manufactured after August 20, 1986.  It must prevent automatic restart after an 
interruption due to remote interlock activation or from an interruption for more 
than 5 seconds due to unexpected loss of main electrical power. 
 
 
LABELING  REQUIREMENTS 
 
A warning logotype [1040.10(g)(1),(2),(3)] is required on Class II, IIIa, IIIb, 
and IV laser products.  The regulations specify the warning statement and 
design, by product Class, for visible radiation.  If there is emission in the 
ultraviolet or infrared spectrum there must be a warning for invisible radiation 
as well [1040.10(g)(8)].  The CAUTION warning logotype is for Class II laser 
products and for IIIa laser products that have an irradiance not exceeding 2.5 x 
 
Laser Compliance Guide (6/92)  Page 9  10-3W cm-2.  The DANGER warning is for Class IIIa laser products that have an 
irradiance exceeding 2.5 x 10-3W cm-2, and for Class IIIb and IV laser products. 
 
A specific warning statement without logotype is required on Class IIa products 
[1040.10(g)(1)(i)]. 
 
The warning logotype must also contain [1040.10(g)(4)] a statement of the 
maximum output, pulse duration (if pulsed), and the laser medium or emitted 
wavelength(s). 
 
Removable or displaceable protective housings [1040.10(g)(6),(7)] that are not 
safety-interlocked or that have defeatable safety interlocks also require 
warning labels.  The severity of the warning depends on the type and level of 
the interior laser radiation.  Wording is specified; invisible, electromagnetic, 
and x radiation must also be indicated if present.  Labeling must also be 
visible on the product prior to and during removal or displacement of the 
housing and close to the opening involved. 
 
An aperture warning label is required for each aperture through which laser 
radiation in excess of Class I or IIa or collateral radiation in excess of Table 
VI is emitted during operation [1040.10(g)(5)].  Wording is specified; 
invisible, electromagnetic, and x radiation must also be indicated if present. 
 
A certification label is required (1010.2) and must state that the manufacturer 
certifies that the product complies with the standard or with an approved 
variance.  The certification statement must appear on a label on the product and 
make specific reference to the regulations with which the product complies.  
Minimum suitable statements would include: 
 
  "Complies with 21 CFR Chapter 1, Subchapter J."  or  
  "Complies with 21 CFR 1040.10 and 1040.11." 
 
An identification label must be provided and must contain the name and address 
of the manufacturer and the place, month, and year of manufacture; the month and 
year of manufacture may not be abbreviated (1010.3).  Alternate brand names, 
other company names, or a coded place of manufacture may be used if an 
explanation is provided to CDRH. 
 
All required labels must be permanently affixed, and must be readable without 
requiring exposure to levels exceeding Class I. 
 
Note:  If certain labeling requirements are inappropriate for your product, you 
may apply for approval of alternate labeling. 
 
 
INFORMATIONAL  REQUIREMENTS 
 
Informational requirements apply to user information for operation and 
maintenance, to purchasing information such as brochures and specification 
sheets, and to servicing information. 
 
User information must contain [1040.10(h)(1)]: 
 
Laser Compliance Guide (6/92)  Page 10     
  (cid:129)instructions for operation and maintenance, with appropriate warnings to 
avoid exposure; 
   
  (cid:129)radiation specifications; 
   
  (cid:129)reproductions and locations of labels that are required by the standard and 
that are accessible during operation and maintenance; 
 
  (cid:129)a listing of all controls and adjustments; and 
 
  (cid:129)a caution statement, as specified in the regulations, concerning possible 
hazardous exposure if instructions are not followed.  Note:  If this 
warning statement is not appropriate to your product, you may request 
approval of a more specific warning better suited to your product. 
 
Additional requirements for certain laser workstations are contained in Laser 
Notice # 39, that addresses the multi-axis, robotic, high power laser 
workstations that are not Class I due to the need to accommodate all sizes of 
workpieces.  The notice discusses hazards unique to these products and proposes 
specific information required in the user's manual.  This includes identifying 
the locations around the workstation where laser radiation levels may exceed 
Class I and the Maximum Permissible Exposure (MPE) boundaries.  Remember that 
the operator must be able to operate the machine from a Class I area, per 
1040.10(f)(7), so special shielding may be required.  See the notice for further 
instruction. 
 
Brochures and specification sheets must include a reproduction (color optional) 
of a complete warning logotype or Class IIa warning statement as required on the 
product [1040.10(h)(2)(i)]. 
 
Servicing information must contain [1040.10(h)(2)(ii)]: 
 
  (cid:129)procedures for service with appropriate warnings to avoid exposure; 
 
  (cid:129)a schedule of maintenance to maintain the product in compliance; 
 
  (cid:129)a listing of controls that could increase the level of accessible radiation; 
 
  (cid:129)identification of removable portions of protective housings; 
 
  (cid:129)procedures to avoid exposure; and 
   
  (cid:129)reproductions of required labels (color optional) and warnings. 
 
At the discretion of the manufacturer, user and service information may or may 
not appear in the same manual.  Service procedures, however, must be clearly 
identified as such.  In many cases, the classification of a given procedure as 
maintenance or service determines whether a safety interlock is required. 
 
 
REQUIREMENTS  FOR  SPECIFIC-PURPOSE  PRODUCTS 
 
Laser Compliance Guide (6/92)  Page 11   
Medical laser products are laser products that are medical devices manufactured, 
designed, intended, or promoted for in vivo irradiation of the human body for 
diagnosis, surgery, therapy, or determining relative position 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 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)]. 
 
Please note that, according to the definition given in 1040.10(b)(26), a medical 
laser product may not be a medical device.  However, if you need information on 
the medical device regulations, premarket approval and notification procedures, 
investigational device exemptions, registration and device listing, please 
contact DSMICA at 1-800-638-2041. 
 
Surveying, leveling, and alignment laser products are generally used in 
agriculture and in the construction industry.  They are restricted to 5 mW 
visible radiant power and to Class I for other wavelengths and pulses less than 
3.8 x 10-4 seconds [1040.11(b)]. 
 
Demonstration laser products [1040.10(b)(13)] include: 
   
  (cid:129)laser products promoted for classroom demonstration of optical phenomena; 
 
  (cid:129)artistic displays and their associated apparatus; 
 
  (cid:129)laser light show projectors; and 
 
  (cid:129)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 Appendix B, Clarification of Certain Laser Light Show Requirements, for 
more information. 
 
Class II and IIIa laser light show projection systems provide effective shows in 
certain venues such as nightclubs and small theaters.  Although Class I, II, and 
IIIa laser light shows need not be reported to CDRH, manufacturers of the 
projection systems must certify and report their products.  CDRH has issued 
Laser Notice # 40 (October 29, 1987) which provides detailed guidance with 
operator's instructions, in order to assure safe installation and production of 
 
Laser Compliance Guide (6/92)  Page 12  safe shows.  The notice discusses installation restrictions, scanning 
safeguards, laser power measurements, specific requirements for user 
instructions, and advertising. 
 
It is mandatory that laser projectors never expose an audience to laser 
radiation greater than Class I levels of radiation.  A projector cannot be used 
for audience scanning unless it is equipped with an adequate scanning safeguard. 
 See Appendix B for further clarification. 
 
 
  RECORDKEEPING, REPORTING, AND NOTIFICATION 
 
RECORDKEEPING 
 
The certification of compliance that the manufacturer places on the product must 
be based upon a testing program that is adequate to ensure the claimed 
compliance [1010.2(c)].  A thorough discussion of adequacy of testing programs 
is contained in HHS Publication FDA 76-8036, "Quality Control Practices for 
Compliance with the Federal Laser Product Performance Standard."  If CDRH 
believes a manufacturer is not operating in a state of control so as to assure 
product compliance, the testing program may be disapproved, making further 
introduction of the product into commerce illegal until such time as the testing 
program is re-evaluated and approved. 
 
Manufacturers are required to maintain records (1002.30) that include: 
 
  (cid:129)a written description of the quality control procedures; 
 
  (cid:129)results of tests or checks for compliance with the standard; 
 
  (cid:129)results of life testing to substantiate that the product will not emit 
increased levels of radiation with age as a result of deterioration and 
that the product can be expected to remain in compliance when maintained 
in accordance with the procedures given in the user and servicing 
information; 
 
  (cid:129)copies of written communications between the manufacturer and dealers, 
distributors, and purchasers concerning radiation safety, including 
complaints and instructions; and 
 
  (cid:129)distribution of the products, to permit tracing in the event of recall.3 
 
Manufacturers must preserve the required records for a period of 5 years; must, 
upon reasonable notice, permit FDA to inspect the records; and must submit 
copies of records to CDRH upon request (1002.31). 
 
Dealers and distributors must also maintain distribution records to permit 
tracing in the event of recall (1002.40).  Distributors  may  furnish the 
                     
          3Effective  August  20,  1986,  distribution  records  must  be  maintained  for  noncertified  laser
products sold as components to original equipment manufacturers. See 1040.10(a)(3). 
 
Laser Compliance Guide (6/92)  Page 13  distribution records to the manufacturer or retain the records themselves.  
Distributors who elect to maintain the records must: 
 
  (cid:129)notify the manufacturer, in writing, of their intention to maintain the 
records; 
 
  (cid:129)maintain the records for a period of 5 years or, if they cease distribution, 
furnish the required information to the manufacturer;  and 
 
  (cid:129)provide the information to the manufacturer when advised by the manufacturer 
or by CDRH that the information is required for a product recall. 
 
 
REPORTING  AND  NOTIFICATION 
 
Manufacturers are required to furnish reports to CDRH to substantiate compliance 
with the standard, to describe the testing program, and to provide other 
information.  Laser Product Reports are used to describe the: 
   
  (cid:129)reported product and labeling; 
   
(cid:129)manner in which the product complies with the standard; 
   
(cid:129)testing program to assure compliance; 
   
(cid:129)life testing; and 
   
(cid:129)test equipment used. 
 
The first submission of a Laser Product Report (1002.10) by a manufacturer was 
originally designated an Initial Report, with all subsequent reports on new or 
different models called Model Change Reports.  Since these reports contain 
essentially the same information, the single term, Product Report, is now used. 
 Changes in a reported model should generally be reported in a supplement to the 
Product Report on that model. 
 
Manufacturers are required to submit the Product Report prior to introduction of 
the certified product into commerce.  CDRH considers delivery of a product to a 
prospective purchaser or for exhibition at a trade show to be introduction into 
commerce.  CDRH has issued a "Guide for Preparing Product Reports for Lasers and 
Products Containing Lasers," and a "Reporting Guide for Laser Light Shows and 
Displays."  The appropriate Guide must be used and the report format must follow 
that of the Guide [1002.7(b)]. 
 
An individual or firm that makes only one unit of a product on an occasional 
basis is nevertheless considered to be a manufacturer and must certify and 
report such units.  The report may in some cases be briefer, especially in the 
area of quality control procedures.  However, the report must clearly describe 
the product and how it complies.  The manufacturer of such products is 
encouraged to point out that the report is for a product manufactured on a one-
time, one-unit basis. 
 
 
Laser Compliance Guide (6/92)  Page 14  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. 
 
Several Laser Notices have been issued identifying certain categories of low 
power laser products that have been exempted from certain reporting and 
recordkeeping requirements.  Notice # 36 (August 23, 1985) and # 41 (August 9, 
1988) deal with products that are inherently Class I.  A complete listing is 
available from DSMA. 
 
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 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 require all of the above plus Supplemental 
Reports when the criteria requiring submission of Supplemental Reports are met. 
  
 
Annual Reports (1002.13) summarize the records the manufacturer is required to 
maintain (1002.30).  Annual Reports must be submitted by September 1 of each 
year for the year ending the preceding June 30.  Each year, CDRH provides 
guidelines for submission of Annual Reports that must be followed [1002.7(b)]. 
 
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, or if they 
have been exempted from reporting as a Product Report, then the manufacturer 
need only identify them in their Annual Report, or in quarterly updates to the 
Annual Report.  Such model numbers should be reported in quarterly supplements 
to the Annual Report.  Quarterly updates should be clearly marked as such and 
submitted prior to December 1, March 1, or June 1, as needed.  Copies of the 
Annual Report form to be followed are available from DSMA by calling 1-800-638-
2041. 
 
Accidental radiation occurrences must be reported to CDRH by manufacturers 
(1002.20), regardless of whether injury occurred.  The report must include 
identification of the product involved, the circumstances and details of the 
incident, and actions taken to prevent recurrence. 
 
Radiation defects or failure to comply with the standard must be reported to 
CDRH (1003.10).  Notification must also be provided to distributors and 
purchasers. 
 
 
  PRODUCT  RECALLS 
 
 
Laser Compliance Guide (6/92)  Page 15  Manufacturers may be required to recall a laser product (1003), i.e., repair or 
replace it or refund its purchase price, if the product fails to comply with the 
standard or has a radiation defect (1003.2). 
 
Notification to CDRH is required if the manufacturer becomes aware that a 
product is defective or fails to comply (1003.10).  Notification must be sent 
immediately to CDRH and with reasonable promptness to distributors and 
purchasers. 
 
Notification to the manufacturer will be made if CDRH becomes aware (through 
product inspection or report review) of a defect or failure to comply (1003.11). 
 The manufacturer will be advised of these findings and will be given a 
reasonable time to refute the claimed defect or noncompliance. 
 
Notification to distributors and purchasers is required (1003.21) if the 
manufacturer does not successfully refute the alleged defect or noncompliance or 
is not granted an exemption from the requirements for notification and repair.  
CDRH will review the draft of the notification to avoid the need for a second 
notification. 
 
The manufacturer must also provide to CDRH a report (1003.20) stating: 
 
  (cid:129)the total number of products so produced; 
 
  (cid:129)the location of the violative products; 
 
  (cid:129)an evaluation of the resultant hazards; and 
 
  (cid:129)a corrective action plan (CAP) (1004). 
 
Each corrective action plan is reviewed and may be approved with any necessary 
changes or conditions.  The manufacturer must then implement the approved plan. 
 FDA field offices monitor corrective actions for effectiveness. 
 
An exemption from the requirements for notification and corrective action may be 
requested if the manufacturer can demonstrate that the defect or noncompliance 
does not create a significant risk of injury (1003.30 and 1003.31). 
 
A manufacturer may not legally introduce products into commerce that have a 
radiation defect or that fail to comply with the standard.  Shipments of 
violative products must cease when the manufacturer becomes aware of a defect or 
noncompliance.  Shipments of corrected products may be made following changes to 
achieve compliance.  Submission of a supplement to the Laser Product Report on 
the product that details how the product now complies is required prior to 
resumed introduction. 
 
 
VARIANCES AND EXEMPTIONS 
 
The regulations allow for variances and exemptions from all or part of the 
standard and from the reporting and recordkeeping requirements. 
 
 
Laser Compliance Guide (6/92)  Page 16  A variance (1010.4) is permission to vary from one or more requirements of the 
standard.  Upon application by a manufacturer, the Director of CDRH may grant a 
variance for a product if it is determined that the variance is so limited in 
applicability that an amendment to the standard is not justified, or is of such 
need that there is not sufficient time for amending the standard, and that 
granting the variance is in agreement with the Federal Food, Drug, and Cosmetic 
Act.  Specifically, a variance may be granted if: 
 
  (cid:129)there are alternate but at least equal means of safety; or 
 
  (cid:129)there are suitable means of safety and, further, either the product could not 
perform its function if it were in compliance, or one or more requirements 
of the standard are inappropriate for the product. 
 
In requesting a variance, a manufacturer should carefully follow the format for 
submission set forth in the regulations [1010.4(b)].  Failure to provide all the 
required information may result in delay in issuance of the variance; the 
variance is required before the product may be introduced into commerce. 
 
Exemptions from the standard and from the recordkeeping and reporting 
requirements have been granted to several Federal agencies (1010.5), including 
the Departments of Defense and Energy, some NASA facilities, and NOAA, for 
certain unique or classified products.  Vendors to these agencies should inquire 
through the contracting officers whether the products being purchased are 
covered by the exemptions. 
 
Manufacturers of certain specialized products may also be exempted from annual 
reporting and recordkeeping (1002.50).  Manufacturers who wish such an exemption 
should apply by submitting, with the Laser Product Report, justification and 
evidence showing that: 
 
  (cid:129)the product cannot under any conditions emit levels of radiation that are 
hazardous; or 
 
  (cid:129)the product is produced in such small numbers that the need for continuous 
reporting and recordkeeping is negated, and the product is to be used by 
individuals trained and knowledgeable in the hazards of such use. 
 
The Director of CDRH may also exempt manufacturers from any part of the 
reporting and recordkeeping requirements if the exemption is judged to be in 
keeping with the purposes of the FFDCA. 
 
Laser Compliance Guide (6/92)  Page 17   
APPENDIX A. TABULATION OF FDA REQUIREMENTS FOR LASER PRODUCTS 
 
Requirements                Class1 
 
                    I  IIa  II  IIIa  IIIb  IV 
 
Performance (all laser products) 
Protective housing (1040.10(f)(1))      R2  R2  R2  R2  R2  R2 
Safety interlock (1040.10(f)(2))      R3.4  R3.4  R3.4  R3.4  R3.4   R3.4 
Location of controls (1040.10(f)(7))    N/A  R  R  R  R  R 
Viewing optics (1040.10(f)(8))      R  R  R  R  R  R 
Scanning safeguard (1040.10(f)(9))      R  R  R  R  R  R 
 
 
Performance (laser systems) 
Remote control connector (1040.10(f)(3))  N/A  N/A  N/A  N/A  R  R 
Key control (1040.10(f)(4))       N/A  N/A  N/A  N/A  R  R 
Emission indicator (1040.10(f)(5))      N/A  N/A  R  R  R10  R10 
Beam attenuator (1040.10(f)(6))      N/A  N/A  R  R  R  R 
Reset (1040.10(f)(10))          N/A  N/A  N/A  N/A  N/A  R13 
 
 
 
Performance (specific-purpose products)    
Medical (1040.11(a))          S  S  S  S8  S8  S8 
Surveying, leveling,alignment(1040.11(b))  S  S  S  S  NP  NP 
Demonstration (1040.11(c))        S  S  S  S11  S11  S11 
 
Labeling (all laser products) 
Certification & identification (1010.2, .3)  R  R  R  R  R  R   
Protective housing (1040.10(g)(6),(7))    D5  R5  R5  R5  R5  R5 
Aperture (1040.10(g)(4))          N/A  N/A  R  R  R  R 
C lass warning (1040.10(g)(1),(2),(3))    N/A  R6  R7  R9  R12  R12 
Information (all laser products) 
User information (1040.10(h)(1))      R  R  R  R  R  R 
Product literature (1040.10(h)(2)(i))    N/A  R  R  R  R  R 
Service information (1040.10(h)(2)(ii))   R  R  R  R  R  R 
 
Legend 
R       - Required 
N/A     - Not applicable. 
S       - Requirements: Same as for other products of that Class. Also see  footnotes. 
NP      - Not permitted. 
D       - Depends on level of interior radiation. 
 
 
15 
 
 
 
Footnotes 
1 Based on highest level accessible during operation. 
2  Required wherever & whenever human access to laser radiation above Class  I limits is 
not needed for product to perform its function. 
3 Required for protective housings opened during operation or maintenance,  if human 
access thus gained is not always necessary when housing is   open. 
 
Laser Compliance Guide (6/92)  Page 18  4 Interlock requirements vary according to Class of internal radiation. 
5 Wording depends on level & wavelength of laser radiation within   protective housing. 
6 Warning statement label. 
7 CAUTION logotype. 
8 Requires means to measure level of laser radiation intended to irradiate  the body.  
9 CAUTION if 2.5 mW cm-2 or less, DANGER if greater than 2.5mW cm-2. 
10 Delay required between indication & emission. 
11 Variance required for Class IIIb or IV demonstration laser products and  light shows. 
12 DANGER logotype. 
13 Required after August 20, 1986. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16 
 
 
 
 
 
 
Laser Compliance Guide (6/92)  Page 19  APPENDIX B:  CLARIFICATION  OF  CERTAIN  LASER  LIGHT  SHOW  REQUIREMENTS 
 
 
The Center for Devices and Radiological Health (Center) is concerned that there are a 
number of areas of confusion in the understanding of the requirements for Class IIIb and 
IV laser light shows and devices.  In addition, several of the conditions used in most 
variances are not understood and are being ignored.  This notice provides guidance to help 
manufacturers understand (1) what a variance is, (2) who is or is not covered by a 
specific variance, (3) when a variance must be amended, (4) what the various reporting and 
notification conditions mean, (5) the role of the laser product reporting guide, the laser 
light show reporting guide, and the notification letter, and (6) what certain 
misunderstood variance conditions actually mean. 
 
  VARIANCE (21 CFR 1010.4) 
 
A variance is a formal permission to deviate from a requirement of the regulations.  For 
laser light shows and devices, a variance permits use of laser radiation levels that 
exceed the limits (Class IIIa) for demonstration laser products as specified in 21 CFR 
1040.11(c).  A variance for laser light shows and devices is generally granted based on a 
determination that the product is required to perform a function which cannot be performed 
with equipment in compliance with the standard and that suitable means of radiation safety 
and protection will be provided.  These suitable means are specified in the conditions of 
the variance and constitute, together with the balance of the laser product performance 
standard, an individual performance standard for a specific manufacturer of those specific 
laser products that may be certified by the manufacturer under the variance.  Several 
points require additional comment. 
 
 
1.The approval of a laser light show variance is limited to approval of the conditions of 
the variance that specify the required means of radiation safety and protection that apply 
to the laser products covered by the variance.  This approval in no way constitutes FDA 
approval, certification, or endorsement of those laser products produced under the 
variance.  Further, the variance is not a license for the manufacturer, because the 
approval of a variance does not depend on a determination of the competence of the 
manufacturer to meet the specified conditions.  The manufacturer is responsible for 
ensuring by suitable quality control/assurance procedures that each product complies with 
all requirements of the variance and the laser product performance standard, and to so 
certify in a label on the laser product.  In order to meet this responsibility, it may 
indeed be necessary for a manufacturer to expand his technical capabilities.  
Manufacturers who fail to demonstrate basic technical capabilities essential to ensure 
safety may have their variances revoked. 
 
2.Some manufacturers do not understand clearly that there are two laser light show 
products involved in any laser light show.  One is the basic projection and central 
control system which constitute the source of the laser light.  The second product is the 
laser light show itself which includes the basic projector and all the auxiliary 
components (such as projection surfaces or screens, remote scanning components, mirror 
balls, fixed mirrors, termination targets, etc.) in their final assembled configuration at 
a given performance site.  Both of these laser light show products are subject to the 
laser standard, must be reported, and must be covered by an approved variance(s) if the 
level of laser radiation emitted by the projector exceeds the limits of Class IIIa.  Thus, 
a laser light show projector manufacturer must have an approved variance under which a 
 
Laser Compliance Guide (6/92)  Page 20  Class IIIb or IV projector may be certified.  Likewise, a laser light show/display 
manufacturer must have an approved variance under which the Class IIIb or IV laser light 
show/display may be certified.  If the laser light show manufacturer also manufactures the 
projector, then that manufacturer must have an approved variance under which both the 
projector and the laser light show may be certified. 
 
3.A variance is a special performance standard, not a general standard. As such, it is 
limited to cover certain specific products and is only applicable to such products 
produced by the variance holder.  Thus, a variance is not transferrable from one 
manufacturer to another.  Also the holder of the variance may not introduce equipment that 
was not specifically covered by the variance.  For example, a laser projector manufacturer 
(A), who has a variance covering his projector and his light shows incorporating that 
projector and certain auxiliary equipment, cannot transfer the coverage of his variance to 
light show manufacturer (B), who purchases the projector and incorporates it with 
equipment he (B) already has, to make a light show.  In such a case manufacturer (B) would 
be required to obtain his own variance for laser light shows.  Also, manufacturer (A) 
could not incorporate other equipment unless this equipment is included in his variance. 
 
 
  VARIANCE AMENDMENTS [21 CFR 1010.4(b)(2)] 
 
 
A variance may need to be amended and reports submitted if the product is changed.  The 
necessity of amending the variance is determined by whether the change(s) to the projector 
or light show would be a substantial change that required changing the conditions of the 
variance to achieve the required radiation safety and protection.  Thus, when effects that 
were not previously included in the variance application are added, or when the variance 
was granted for a Class IIIb light show and a Class IV light show is being planned, or 
when types of lasers and/or projectors other than those originally listed in the variance 
application are incorporated, an application for an amendment to the variance should be 
submitted to the FDA Division of Dockets Management using Form FDA-3147.  The Center 
recognizes that it may be difficult for the manufacturer to make the needed determination 
in every case.  In such a situation, the manufacturer is urged to contact the Electronic 
Products Branch at (301) 594-3332 for assistance in determining whether an amendment is 
required.  
 
As a matter of policy, the Center encourages manufacturers to minimize the need for 
amendments by making the initial variance application as broad as possible. 
 
 
  REPORTING (21 CFR 1002.10 and 1002.12) 
 
In addition to the variance or variance amendment required for Class IIIb and IV laser 
light show or display products, such products of all classes must be reported to the 
Center.  To satisfy this reporting requirement you must submit: 
   
  (1)a report on the laser projection system equipment, including any auxiliary 
components, in accordance with the general reporting guide, "Guide for Preparing 
Laser Product Reports," dated __???????__ ; 
 
(2)a detailed report on the laser light show or display, including quality control or 
testing procedures, set-up procedures, installation diagrams, and the types of 
 
Laser Compliance Guide (6/92)  Page 21  effects incorporated into the laser light show, in accordance with the "Reporting 
Guide for Laser Light Shows and Displays (21 CFR 1002)" dated March 1980; and  
 
(3)a notification to the Center, as soon as possible, containing the specific date(s) and 
location(s) with complete addresses for each assembly and presentation of the 
laser light show and the specific laser effects to be produced in each laser 
light show.   
 
The combination of all the information in the above submissions must be adequate for the 
Center to determine what effects are being used in any given show, what relationships 
exist between the locations of Class III and IV laser radiation levels and the locations 
of people present at the laser light show, and that the projector and the show comply with 
the conditions of the applicable variance(s) and the laser standard.  If the information 
submitted is inadequate to permit the Center to make such determinations, then the 
reporting and notification requirements have not been satisfied. 
 
In satisfying the reporting requirements indicated above, it is permissible to:   
 
  (1)Use the general reporting guide to provide the report required for all projectors, 
projection systems, and auxiliary components.  In your report you must describe those 
aspects of the design of your product that satisfy specific requirements of the 
standard and of your variance. 
 
    (a)If you are the manufacturer of the projector and the light show, then the general 
reporting guide must be used to provide a complete report on the whole projection 
system.  This system must identify the auxiliary components in the projection 
system and describe any aspects of the design of those components that satisfy a 
requirement of the variance or the standard. 
 
    (b)If the projector or projection system was purchased and is certified by its 
manufacturer, you may provide the information concerning the projector by 
reference to the manufacturer's report on the projector or projector system 
specifying the model number, and model name, and the Accession Number of that 
report.   
 
    (c)If you have modified the projector or added auxiliary equipment such as mirrors, 
mirror balls, remote scanners, screens, etc., the modified projection system must 
be reported using the general reporting guide.  As above, the projector 
manufacturer's report may be referenced for any items of information that were 
not affected by the modification(s). 
 
(2)Use the Laser Light Show Report Guide (March 1980) to provide the following 
information.   
 
    (a)Fixed effects repertoire, such as for a touring show: 
 
      (cid:129) Set-up procedures. 
 
      (cid:129)Quality control and testing procedures including checklists or test record 
forms used on-site to assure compliance. 
 
 
Laser Compliance Guide (6/92)  Page 22        (cid:129)General description of all planned effects and the means employed to assure 
their compliance. 
 
      (cid:129)General diagrams of an installation including plan and elevation drawings 
showing laser beam paths or scanned fields, audience and 
performer/operator/worker locations, clearance dimensions, etc. in sufficient 
detail to show the spatial relationship of the audience and of the 
performers/operator/workers to regions where Class IIIb or IV levels of laser 
radiation may be present. Sufficient information must be provided to show how 
your laser light show complies with your variance conditions. 
 
    (b)Permanent and semi-permanent shows: 
 
      (cid:129)The written quality control or testing procedures including any checklists and 
test record forms used for set-up and subsequent performances to assure initial 
and continued compliance. 
 
      (cid:129)Specific description of the effects in the show and the means employed to 
assure their compliance. 
 
      (cid:129)Specific diagrams of the installation providing the same type of information 
listed above for touring shows. 
 
    (c)Special Project Shows (such as a one-time engagement): 
 
      (cid:129)Description of all proposed effects and the means for assuring compliance. 
 
      (cid:129)Quality Control and testing procedures to cover all types of installation, 
e.g., outdoor, indoor, etc., and all proposed effects. 
 
      (cid:129)Although specific installation diagrams for such individualized shows may not 
be possible at the time of reporting, provide as much detail as possible to show 
that you understand how to comply with the conditions of your variance in the 
location in which you plan to perform the show. 
 
(3)Use the notification letter to provide the following information on a laser light show: 
  
 
    (a)Show schedule including the date(s), time(s), and location(s) (giving the full 
address) for each show or for a complete tour.  Each outdoor show must be clearly 
identified as such.  
 
    (b)By reference to the appropriate laser light show report, indicate the effects 
planned for the show(s). 
 
  (c)Diagrams of the installation providing the information requested above, if such 
applicable diagrams have not been previously provided in a report.  If diagrams 
have been previously submitted, please specifically reference them. 
 
The Center is willing to be flexible regarding which submission, the notification letter 
or the laser light show report, contains specific information.  However, the failure of 
the total information provided in these submissions to describe the manner of compliance 
 
Laser Compliance Guide (6/92)  Page 23  with the conditions of your variance is a violation of P.L. 90-602 and 21 CFR 1002.10 and 
1002.12.  Repeated failures to report or inadequate reporting will be grounds for 
revocation of a variance.  Also, failure to provide timely notifications of show schedules 
and effects is a violation of a condition of your variance and may result in an amendment 
requiring 30 days advance notice for all of your shows or, in the worst cases, revocation 
of the variance. 
 
 
  CLARIFICATION OF CERTAIN VARIANCE CONDITIONS 
 
1. Audience Scanning and Scanning Safeguards 
 
Any scanning effect that may expose members of the audience to the scanned laser radiation 
either directly from the projector or indirectly by nearly specular reflection from some 
auxiliary component of the projection system is considered to be audience scanning.  When 
the scanned laser radiation has peak power levels above 5 mW, there is an acute risk of 
injury to someone's eyes if the scanning were to stop or slow down to a rate that would 
produce Class IIIb or IV levels of laser radiation.  Thus a requirement for a scanning 
safeguard is included in every variance that covers any type of scanning effect. 
 
The scanning safeguard condition in the laser light show product variances is very similar 
to the scanning safeguard requirement specified in the laser product performance standard. 
 However, the variance condition is more explicit in several respects.  First, the 
"accessible emission limit(s) which are applicable to the scanned laser radiation" are 
specifically indicated, i.e., Class I limits apply to laser radiation in audience areas 
and Class I or II limits apply for show personnel depending on whether or not the laser 
light must be viewed by these personnel during the performance of their duties.  Second, 
the requirement that an adequate scanning safeguard must have a short enough reaction time 
to prevent human exposure to laser radiation in excess of the applicable accessible 
emission limit(s) is explicitly stated.  Because of the high risk of injury to someone's 
eyes, this latter item is considered to be a critical performance feature for any Class 
IIIb or IV laser light show that would employ scanning effects directed into the audience. 
 Satisfying this condition has also proven to be a very difficult technical problem. 
 
To understand why this is so, consider an audience scanning situation in which a 1 W beam 
is scanning at rates sufficient to achieve laser radiation levels below the Class I limits 
both for single pulses and for average power. If this beam were to stop, the time required 
for the laser radiation to exceed the Class I limit would be 200 nanoseconds.  The 
reaction time of the entire scanning safeguard system from the detection of scan failure 
to attenuation of laser radiation below the Class I limits would have to be less than 200 
nanoseconds if it were triggered when the scanning stopped.  We recognize that this 
hypothetical situation is an extreme limit and that the effects of inertia and other 
factors have not been considered.  These factors may be taken into account if sufficient 
information is provided by the manufacturer to show that the total reaction time needed 
for the level of the scanned safeguard system is shorter than the minimum time needed for 
the level of the scanned laser radiation to exceed the applicable emission limits.  As of 
this time, the Center has not received data to show that any scanning safeguard system is 
adequate for audience scanning, although several manufacturers have discussed various 
types of high-inertia scanning systems that seem promising. 
 
In light shows that employ the reflection of a scanned laser beam off of a rotating mirror 
ball, careful analysis of the configuration is needed to determine whether or not a 
 
Laser Compliance Guide (6/92)  Page 24  scanning safeguard is required on both the projector and the mirror ball.  If either one 
of the scanning systems could be stopped without exceeding the applicable accessible 
emission limits, then that scanning system would not be required to have a scanning 
safeguard.  The Center's experience with laser light shows indicates that the projectors 
scanning small diameter beams onto mirror balls generally need a scanning safeguard, 
although the need for a scanning safeguard on the mirror ball depends on such factors as 
the beam peak power and the minimum size of the scan pattern at the mirror ball. 
 
2.  Beam Stops/Overfilling Mirrors 
 
In laser light shows that contain aerial beam patterns formed by projection to termination 
points or reflection by one or more fixed mirrors to a termination point, adequate means 
to terminate or contain any laser radiation must be provided for each remote mirror and 
the final termination target.  Of concern in this requirement is the assurance that laser 
radiation that misses a mirror due to overfilling the mirror or beam movement will be 
terminated by some suitable beam stop or beam containment and thus be prevented from 
projection directly or by reflection into areas that may be occupied.  In assessing 
whether or not the mirror is overfilled it is necessary to consider the low-angle forward-
scattered laser radiation that would project into areas that may be occupied and whether 
this radiation would exceed the applicable limits in the occupiable area.  If the forward-
scattered laser radiation were to exceed the applicable limits it would have to be 
terminated if it misses the mirror.   
 
However, under the following conditions in some laser light shows, adequate protection may 
be provided without the use of beam stops: 
 
a.The areas of potential projection are occupied only by employees; 
 
b.The employees are educated by the laser safety officer concerning the hazards; and 
 
c.Control measures (posting warning signs and marking hazard areas) are implemented as 
discussed in the next section. 
 
The condition specifying the beam stop requirement suggests that the beam stop should 
subtend an angle of 50 milliradians (3 degrees) from the projector.  This is a suggestion. 
 If the beam and any forward scatter can be adequately terminated by a smaller beam stop, 
that is acceptable. 
 
In outdoor shows, the size of the beam stop can present considerable wind resistance and 
may make the mirror unstable if attached to the same mount.  Under such conditions, 
independent mountings for the mirror and the beam stop may be needed. 
 
The other requirement specified in the condition covering remote mirrors is that the 
mounting must be secure.  This covers two concerns.  First, the mounting must be a sturdy 
design that provides for a very positive locking of the mirror's orientation.  Second, 
there must be adequate protection in the context of the specific show or display to 
prevent accidental misalignment of the mirrors by someone bumping into them or dropping 
something on them.  In some situations, there may have to be beam containment enclosures 
or baffles to prevent a beam from a misaligned mirror from entering audience areas.  The 
Center's concern for adequate protection from accidental mirror misalignment increases 
when the beams have a long projection range and the allowable angular deviation is quite 
small. 
 
Laser Compliance Guide (6/92)  Page 25   
3.  Set-up Safety Control Measures 
 
The condition requiring the use of minimum possible beam power and the use of control 
measures in accordance with a recognized safety standard during set-up, alignment, and 
testing procedures appears to be commonly misunderstood.  Low beam power for these initial 
procedures is generally used, but use of the control measures is overlooked in too many 
cases.  The manufacturer is responsible for becoming familiar with the control measures of 
recognized laser safety standards (such as ANSI Z136.1) and applying them during set-up, 
alignment, and testing procedures, and during the show, as well as to any areas that may 
be occupied by anyone other than members of the audience.  Such control measures are not 
difficult, but do require some planning to implement.  In general, all personnel not 
needed for the alignment should be cleared from the projection area until the initial 
alignment is done.  With planning, a time slot can be agreed to in the contract and a 
minimal interruption of the other aspects of the production set-up will be achieved.  It 
is considered important that the laser light show manufacturer implement such control 
measures because failure to do so makes accidental radiation exposures much more likely to 
occur. 
 
Laser Compliance Guide (6/92)  Page 26