510(k) K223544
K223544 is an FDA 510(k) premarket notification submitted by Guangdong Newdermo Biotech Co., Ltd. for the device "LED light therapy mask (FM-01, FM-02, FM-03)". The FDA issued a decision of Substantially Equivalent on February 23, 2023. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810. Guangdong Newdermo Biotech Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2023
- Date Received
- November 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.