Clearance Summary
CABOCHON SYSTEM received FDA 510(k) clearance under submission number DEN110004, sponsored by Cabochon Aesthetics, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2013-07-12.
- Submission: DEN110004
- Applicant / Sponsor: Cabochon Aesthetics, Inc.
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4790
- Decision date: 2013-07-12
Classification & Regulation
This clearance is catalogued under FDA product code OUP and 21 CFR 878.4790, within the General, Plastic Surgery review panel as a Class II device.