Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration Staff

Issue Date: January 31, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Laser Notice, Radiological Health
Status: Final

Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration Staff

FDA is issuing this guidance to outline, for manufacturers, the FDA’s approach regarding the applicability of FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) laser products to help manufacturers with questions they have raised. This guidance addresses topics including considerations for what is an SLA laser product, examples of SLA and non-SLA laser products, and information on variances and exemptions from SLA laser product class limits.

Download the Guidance Document