Clearance Summary
IPL THERAPY SYSTEM received FDA 510(k) clearance under submission number K101901, sponsored by Beijing Starlight Science & Technology Development. 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 2011-03-08.
- Submission: K101901
- Applicant / Sponsor: Beijing Starlight Science & Technology Development
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2011-03-08
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.