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GUIDANCE DOCUMENT

Investigational Medical Laser Significant Risk Device (Laser Notice 31) May 1981

Final

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

Center for Devices and Radiological Health

This guide provides: Criteria for Considering an Investigational Medical Laser Device as a Significant Risk Device

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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:

Dockets Management
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.

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