 
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions. PBM devices are for use in aesthetics, dermatology, and other general indications.
This draft guidance outlines the FDA’s proposed recommendations for manufacturers when submitting premarket notification [510(k)] submissions for class II PBM devices, sometimes called low level light therapy (LLLT) devices, and for devices with PBM components.
This draft guidance, if finalized, is intended to:
- Promote consistency and facilitate efficient review of premarket submissions.
- Apply to PBM or LLLT devices that are for use in aesthetics, dermatology, and other general indications.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance under docket number FDA-2022-D-3116 at www.Regulations.gov by March 13, 2023 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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