Clearance Summary
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) received FDA 510(k) clearance under submission number K254007, sponsored by SZ KKS Silicone&Electronic Co., 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 2026-02-12.
- Submission: K254007
- Applicant / Sponsor: SZ KKS Silicone&Electronic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2026-02-12
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.