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GUIDANCE DOCUMENT

Low Power Laser Reporting Exemption (Laser Notice 41) August 1988

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

TO: All Manufactures of Laser Products

SUBJECT: Exemptions from Certain Reporting and Recordkeeping Requirements for Certain Low Power Laser Products.

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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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