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GUIDANCE DOCUMENT

Laser Energy Source (Laser Notice 2) November 1975

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

ADVISORY OPINION: The electron beam accelerator, as a laser energy source, does not meet the criteria for a laser product as defined in paragraph 1040.lO(b)(17). Therefore, it would not be subject separately to 21 CFR 1040.10 and 1040.11.

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