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Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions Draft Guidance for Industry and Food and Drug Administration Staff January 2023


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2022-D-3116

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Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on non-clinical testing, clinical studies, and labeling to support premarket submissions for photobiomodulation (PBM) devices, also known as low level light therapy (LLLT) devices. This guidance applies to class II PBM medical devices regulated under 21 CFR 878.4810, 878.4850, 878.5400, and 890.5500. This guidance also applies to the PBM component of devices that combine a PBM device with another device(s) (e.g., electrostimulation source, mechanical massager, or ultrasound). Some light-emitting products that are intended for only general wellness use and present a low risk to the safety of users and other persons, may not be within the scope of this guidance. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of PBM device submissions.

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