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GUIDANCE DOCUMENT

Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) June 1993

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

The 1985 amendments to the Federal Performance Standard for Laser Products gave the Director, Office of Compliance and Surveillance, Center for Devices and Radiological Health (CDRH) authority to approve, upon written application by the manufacturer, alternate means to accomplish the radiation protection provided by the beam attenuator (21 CFR 1040.10(f) (6) (ii)). This amendment recognized that for many laser products, a beam attenuator, usually a shutter, provides little if any improved safety, especially for laser system that have short beam.

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

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