Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Published

January 12, 2023

Last updated

January 11, 2023

Description

This document is a draft guidance for the industry and FDA staff on premarket notification submissions for Photobiomodulation (PBM) devices.

Organization

Country / Region

United States

License

Other (Public Domain)

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