Clearance Summary
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) received FDA 510(k) clearance under submission number K253878, sponsored by Shenzhen Kaiyan Medical Equipment 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 2026-03-04.
- Submission: K253878
- Applicant / Sponsor: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2026-03-04
Classification & Regulation
This clearance is catalogued under FDA product code OLP and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.