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