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Guidance Issuing OfficeCenter for Devices and Radiological Health
On August 20, 1985, the Food and Drug Administration (FDA) published amendments to the Federal performance standard for laser products. As a result, Class IIIa laser light show products no longer require a variance from the standard for introduction into commerce. There was no change in the requirements for the manufacturer to certify and report the projection system with its supporting literature and the general show configuration prior to its introduction into commerce.
This has resulted in the increased promotion of Class II and IIIa low/moderate power laser products for producing laser light show effects in establishments or at locations having severely restricted space limitations, which, in some cases, may constitute unsafe installation and use of these products.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.