U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Laser Energy Source (Laser Notice 2)
  1. Search for FDA Guidance Documents


Laser Energy Source (Laser Notice 2) November 1975

Docket Number:
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.

Submit Comments

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.

Back to Top