Clearance Summary
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) received FDA 510(k) clearance under submission number K260767, sponsored by Kam Yuen Plastic Products , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-08-31.
- Submission: K260767
- Applicant / Sponsor: Kam Yuen Plastic Products , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2026-08-31
Classification & Regulation
This clearance is catalogued under FDA product code OHS and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.