510(k) K260767
K260767 is an FDA 510(k) premarket notification submitted by Kam Yuen Plastic Products , Ltd. for the device "Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)". The FDA issued a decision of Substantially Equivalent on August 31, 2026. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810. Kam Yuen Plastic Products , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2026
- Date Received
- March 9, 2026
- 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.