Guidance for Industry and FDA 
Staff  
Procedures for Renewal and 
Amendment of Certain Laser 
Light Show Variances 
(Laser Notice 55)  
 
Document issued on September 25, 2007  
 
For questions regarding this document contact L. Dale Smith at 301-796-5868. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
     Food and Drug Administration 
Center for Devices and Radiological Health 
 
                           Electronic Products Branch 
                                       Division of Mammography Quality and Radiation Programs 
                                   Office of Communication, Education, and Radiation Programs  Contains Nonbinding Recommendations 
 
 
Preface 
 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to 
the exact title of this guidance document.  Comments may not be acted upon by the Agency 
until the document is next revised or updated.   
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ocer/guidance/1639.html.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
301-847-8149 to receive a hard copy.  Please use the document number (1639) to identify the 
guidance you are requesting. 
 
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
Procedures for Renewal and Amendment of 
Certain Laser Light Show Variances 
(Laser Notice 55)  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
Introduction 
Under current radiological health regulations,  the Center for Devices and Radiological 
Health (CDRH) may grant manufacturers of electronic products variances from requirements 
of the laser product performance standard subject to any conditions necessary to protect the 
public health and safety (21 CFR 1010.4).  FDA also may amend or withdraw a variance for 
justified reasons (21 CFR 1010.4(c)(2)).  This guidance provides CDRH's explanation of our 
decision to amend specified laser light show variances by changing their termination dates 
and the renewal process for certain laser light show variances currently in effect.  CDRH has 
determined that the variance amendments described below are justified by 21 CFR 
1010.4(a)(2).  Affected variances will continue to provide suitable means for assuring 
radiation safety or protection.  Notification of the amendment will be provided to affected 
variance holders by individually addressed letters. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
and electronic product regulation.  This guidance reflects our careful review of the relevant 
scientific and legal requirements and what we believe is the least burdensome way for you to 
comply with those requirements.  However, if you believe that an alternative approach would 
  1 Contains Nonbinding Recommendations 
 
 
be less burdensome, please contact us so we can consider your point of view.  You may send 
your written comments to the contact person listed in the preface to this guidance or to the 
CDRH Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways 
to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
 
1. Issue 
All manufacturers of demonstration laser products, which includes all laser light shows and 
laser projection systems used in light shows, must comply with the requirements specified in 
Title 21 of the Code of Federal Regulations (21 CFR), Sections 1040.10 and 1040.11.  The 
laser standard limits demonstration laser products to laser emission levels not in excess of the 
limits of Class IIIa in 21 CFR 1040.11(c).  However, many laser light shows are intended to 
be produced in large spaces, requiring the use of laser emission levels of Class IIIb or Class 
IV to produce the desired visual effects. Class IIIb or Class IV shows may be produced only 
when there is a variance approved by CDRH in accordance with 21 CFR 1010.4 permitting 
the use of lasers exceeding the Class IIIa demonstration laser product limit. CDRH believes 
that the variance process is a necessary and appropriate means to ensure public health and 
safety when high power laser beams are used in entertainment and display.  Variance 
renewals have become routine and unnecessarily burdensome when there are no significant 
changes from an existing approved variance.  Therefore, CDRH is now modifying the 
variance renewal and amendment processes to improve the efficiency  
of the process as follows: 
 
  Modifying the renewal and amendment processes to permit automatic renewal of 
certain laser light show variances if required annual reporting requirements are met, 
 
  Amending certain laser light show variances currently in effect to revise their 
termination dates and set conditions for automatic renewal, and  
 
  Amending all variances described in this guidance to permit the addition of any 
certified laser projectors (which are not designed or intended for audience scanning 
effects or projection of invisible laser radiation to produce visible effects) to the 
firm's laser shows without requiring variance amendments. 
 
These modifications in accordance with 21 CFR 1010.4(c)(2) will reduce the regulatory 
burden on manufacturers of laser light shows without compromising the public health. 
 
 
2. Guidance 
What laser light show variances are affected by this guidance?   
  Variances for laser light shows or projectors which do not employ audience scanning 
or exposure effects; and 
 
  2 Contains Nonbinding Recommendations 
 Variances for laser light shows or projectors which produce their visual effects  by 
means of emissions only in the visible wavelength range from 400-700 nm and 
which do not use invisible laser emissions to produce visual effects, and
 Variances for which the types of locations or the types of laser light effects employed
are not changing; and
 Variances which do not permit less than the normal clearance distances; and
 Variances which do not deviate from the other conditions described in the original
variance approval letter issued by CDRH.
What changes are being made to the amendment process and to current variances? 
Manufacturers of Class IIIb and IV laser light shows and/or projection systems, who 
currently have approved variances and meet all of the conditions given above, will have their 
variance amended as follows. 
 The effective date (Paragraph B) of each current variance will be amended by
replacing Paragraph B with a paragraph that will extend the current variance for one
year effective December 31 of the current year on the condition that the required
annual report for the current year has been submitted as required.
 The termination date (Paragraph C) of each current variance will be amended to
become December 31st of the current year if the annual report for the current year has
not been submitted as required.
 Paragraph D of each current variance will be amended to permit the firm to
manufacture and certify Class IIIb or IV laser light show projectors and to
incorporate any Class IIIb or IV laser light show projectors which have been certified
by their manufacturers, with the exception of projection systems designed or intended
to produce visible effects by means of invisible laser emissions and/or to produce
audience scanning effects.
 Variance Attachment A, Condition 2 will be amended by expanding Condition 2 to
require submission of the current annual report as a condition for extension of the
variance on December 31st of the current year and to require that the annual report
have attached a list identifying the manufacturer, model designation, and accession
number for the product report of all the laser projectors used in the firms laser light
shows during the reported year.
3 Contains Nonbinding Recommendations 
 
 
 
  Variance Attachment A, Condition 12 (or, alternately, the equivalent condition 
dealing with setup, alignment, testing procedures and records to be available with a 
show) will be amended to add keeping a copy of Laser Notice 55, the variance 
amendment notice, the firms most recent annual report, and the CDRH 
acknowledgment of receipt of the annual report to the records already included in this 
requirement. 
What conditions apply to these changes?  
  The laser light show manufacturers must currently have approved variances from 21 
CFR 1040.11(c) in effect, and 
 
  The laser light show manufacturers must submit their annual reports every year as 
required by 21 CFR 1002.13.  The regulation specifies that the annual report is due 
by September 1, covering the previous 12 month period from July 1 through June 30. 
 
How will affected variances be amended? 
Each current variance holder will be notified by a letter in accordance with 21 CFR 
1010.4(c)(1) that its variance has been amended in accordance with 21 CFR 1010.4(c)(2).  
The notification will include the amendment specifications and will have this Laser Notice 
(Laser Notice 55) attached. 
What laser light show variances are NOT affected by this guidance? 
Variances for projection systems and laser light shows intended to produce audience 
scanning or visible effects using invisible laser emissions, such as fluorescence or plasma 
breakdown, are not subject to this guidance.  Such projectors and light show effects produced 
in excess of the Class I limits must be specifically approved by CDRH. 
 
  Manufacturers wishing to incorporate or add such products and effects may apply for 
variances (or an amendment to an existing variance) in accord with the process 
described in 21 CFR 1010.4. 
 
  Any variances for which audience scanning or invisible laser emissions are currently 
permitted shall retain the original effective date and termination date and shall be 
subject to renewal in accord with the process described in 21 CFR 1010.4. 
 
Variances requesting additional types of effects to be employed, additional location types 
where shows will be presented, or deviations from the normal clearance or other conditions 
are not subject to this guidance. 
 
  4 Contains Nonbinding Recommendations 
 
 
  Manufacturers wishing make such changes may apply for amendment to their 
existing variances in accord with the process described in 21 CFR 1010.4. 
What requirements must continue to be met for all laser light show and projector 
products? 
Manufacturers must continue to meet requirements for laser light shows and projectors, 
including: 
  21 CFR 1002.10, (Product Reports) requires manufacturers to submit product reports 
for new shows and projectors not yet reported to CDRH. 
 
  21 CFR 1002.11, (Supplemental Reports) requires manufacturers to submit 
supplemental reports for changes to shows and projectors that effect radiation 
emission or manner of compliance with the Federal laser standards. 
 
  21 CFR 1002.20, (Reporting of Accidental Radiation Occurrences) requires 
manufacturers to report incidents involving public exposure to radiation. 
 
  21 CFR 1002.30(a) and 1002.31, (Manufacturer's Records) require manufacturers to 
retain records specified in the regulation. 
 
  21 CFR 1003,  (Notification of Defects or Failure to Comply) requires manufacturers 
to notify CDRH of  products that have electronic product defects or that fail to 
comply with an applicable standard. 
 
  21 CFR 1004 (Repurchase, Repair, or Replacement of Electronic Products) requires 
manufacturers to repurchase, repair or replace products containing a defect or failing 
to comply with an applicable standard. 
 
  All conditions specified in the manufacturers currently approved variances, in the 
variance attachments, and as amended by letter and explained in this guidance. 
Can the Center revoke a variance? 
Yes. CDRH may withdraw any variance if necessary to enforce the Electronic Product 
Radiation Control Provisions of the Federal Food, Drug, and Cosmetic Act and applicable 
regulations.  Such action may be appropriate if CDRH has reason to believe a manufacturer 
is creating a public heath or safety hazard by not complying with applicable requirements 
and the specific conditions of their variance.  
  5 Contains Nonbinding Recommendations 
 
 
3. Getting More Information 
You can get more information about our requirements for lasers from our electronic product 
radiation control web page at http://www.fda.gov/cdrh/radhealth/products/lasers.html.   
If you have questions about this guidance, contact L. Dale Smith, CDRH Office of 
Communication, Education, and Radiation Programs (HFZ-240), 10903 New Hampshire
Avenue, Silver Spring, MD 20993 or l.smith@fda.hhs.gov.  
  6