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GUIDANCE DOCUMENT

Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) October 1987

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center 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.


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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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