Clearance Summary
IPL THERAPY SYSTEM received FDA 510(k) clearance under submission number K123435, sponsored by Beijing Sincoheren S&T Development 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 2013-02-11.
- Submission: K123435
- Applicant / Sponsor: Beijing Sincoheren S&T Development Co, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2013-02-11
Classification & Regulation
This clearance is catalogued under FDA product code ONF and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.