2023-00422: Photobiomodulation Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Photobiomodulation (PBM) Devices--Premarket Notification [510(k)] Submissions." This draft guidance provides recommendations on premarket submissions for photobiomodulation devices, which are used in applications such as aesthetics, dermatology, and other general indications. This draft guidance is not final nor is it for implementation at this time.
The agency’s own summary, as published.
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