Laser Energy Source (Laser Notice 2)
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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.