Responsibilities of Laser Light
Show Projector Manufacturers,
Dealers, and Distributors; Final
Guidance for Industry and FDA
(Laser Notice 51)
Document issued on: May 27, 2001
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Electronic Products Devices Branch
Division of Enforcement III
Office of Compliance Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency
consideration to Dockets Management Branch, Division of Management Systems
and Policy, Office of Human Resources and Management Services, 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.
For questions regarding the use or interpretation of this guidance contact LT Sean
Boyd, USPHS, at 301-796-5895 or by electronic mail at
Sean.Boyd@fda.hhs.gov.
Additional Copies
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/comp/guidance/1349.pdf.   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 (1349) to identify the guidance you are requesting. (cid:10)(cid:13) Responsibilities of Laser Light Show
Projector Manufacturers, Dealers, and
Distributors
This document is intended to provide guidance.  It represents the Agencys current
thinking on this topic.  It does not create or confer any rights for or on any person
and does not operate to bind the Food and Drug Administration (FDA) or the
public.  An alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.
To Laser Light Show Projector Manufacturers, Dealers, and Distributors
Subject Clarification of Responsibilities of Laser Light Show Projector
Manufacturers, Dealers, and Distributors.
Purpose
This guidance clarifies the regulatory requirements that apply to manufacturers who
deliver laser light show projectors to dealers and distributors, and addresses the
corresponding responsibilities of dealers and distributors of laser light show projectors.
Issue
We at the Food and Drug Administrations (FDA) Center for Devices and Radiological
Health (CDRH) receive many inquiries about the specific legal requirements that apply to
laser light show manufacturers and about the related laser light show variance approval
process.  The inquiries suggest that some of you in the laser light show industry, either as
a manufacturer or as a dealer and distributor, may be confused about your regulatory
responsibilities.  We also know that some manufacturers of laser light show projectors
sell equipment to customers without obtaining an approved variance from us, which is
not acceptable.
Background
We may grant a variance from the requirements of the Federal Laser Performance
Standard for Lasers and for demonstration laser products.  The criteria and procedures for
submitting a variance request are explained in detail in federal regulations at 21 CFR sec.
1010.4.  We may grant a variance when you provide an acceptable alternative means of
laser radiation safety and protection where a laser light show projector fails to meet the
requirements of 21 Code of Federal Regulations (CFR) 1040.11(c).  The variance,
therefore, allows you as the manufacturer of laser light show and projector to deviate
Laser Notice 51 from the existing performance standards required by federal regulation.  (See 21 CFR
1040.10 and 1040.11(c).)
As you know, all manufacturers of Class IIIb and IV laser light shows and laser light
show projectors must have approved variances from us to perform laser light shows and
introduce laser light show projectors into U.S. commerce.  Prior to performing laser light
shows or introducing laser light show projectors into U.S. commerce, the manufacturer
must submit the following to us at CDRH:
  A Product Report describing the laser projector
  A Laser Light Show Report describing the laser light show, and
  A variance application requesting permission to deviate from the Federal Laser
Performance Standards.
Only the Laser Light Show Report and variance application must be submitted if an
individual or firm purchases a certified laser projector for which a Product Report has
already been submitted by the projector manufacturer.
These three documents describe how the laser light show and projector comply with the
Federal Laser Performance Standards, how and why these products deviate from the
standards, and what alternative means of laser radiation safety and protection are
provided where these products do not comply with the standards.  A laser light show
production may not begin until we issue a variance approval letter that indicates the
conditions under which the laser light show may be produced.
Several conditions are placed upon performance of laser light shows to protect the public
from exposure to hazardous levels of laser radiation.  One laser light show variance
condition states that laser projectors may only be delivered to customers having an
approved variance.
Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of 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 the information requested
in the guidance is not relevant to the decision-making process or that an alternative
approach would 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 variance
allowing specific use of that projector.  The intent of this condition is to ensure that only
individuals or firms who are aware of laser light show radiation safety and protection
practices and regulatory requirements acquire laser light show projectors.
http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.
Laser Notice 51