Notice:
A laser variance is required to operate any laser in the US over 4.9mw and we are required to make sure you have one. If you already have a laser variance please provide your variance # to us at the email address below so that we can verify it is current and applicable to the laser system you are purchasing. If you do not have a laser variance we can help you acquire one for a fee which depends upon the type of laser system and intended usage. If you would like to obtain a laser variance on your own you can visit the FDA Website:

FDA Web Site Information:

Prior to using Class IIIb and IV lasers for a laser light show in the United States, the following documents must be submitted to the FDA:

• Product Report describing the laser projector
• Laser Light Show Report describing the laser light show
• Application requesting FDA approval for a variance from the demonstration laser product hazard class limit of IIIa (5mW visible output)

These submissions must be prepared with either the CeSub electronic submissions software or the paper reporting guides listed below.
If you are purchasing a certified laser projector for which a product report has already been submitted, you need only submit the laser light show report and variance application.
Your firm can begin to produce laser light shows only after receipt of a variance approval letter from FDA indicating the conditions under which you may produce the laser light show or distribute laser light show projectors.

Submissions / Reporting Forms:

• CeSub Electronic Submissions Program

If you want to submit using CeSub, you should start the FDA Electronic Submissions Gateway setup process now by following the instructions given on: http://www.fda.gov/esg/

Hard Copy Submissions:

• Reporting Guide - Radiation Safety Product Report for Laser Light Shows/Displays, September 1995
• Variance Application for Laser Products used for Light Shows and Displays
• Reporting Guide - Radiation Safety Product Report for Laser Products, September 1995 [Microsoft Word version]
• Reporting Guide - Annual Reports, Revised September 1995 [Microsoft Word version]

Laser Notices:

• Laser Notices to Industry (All)
• Laser Notice 50 - Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Final Guidance for Industry and FDA)
• Laser Notice 51 - Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors (Final Guidance for Industry and FDA)
• Laser Notice 55 - Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Guidance for Industry and FDA Staff)