Clearance Summary
CO2 Laser Machine (Lume) received FDA 510(k) clearance under submission number K250465, sponsored by Nanjing Bestview Laser S&T 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 2025-06-09.
- Submission: K250465
- Applicant / Sponsor: Nanjing Bestview Laser S&T Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2025-06-09
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.