Clearance Summary
ZELTIQ AESTHETICS DERMAL COOLING DEVICE received FDA 510(k) clearance under submission number DEN090002, sponsored by Zeltiq Aesthetics. 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 2010-08-24.
- Submission: DEN090002
- Applicant / Sponsor: Zeltiq Aesthetics
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4340
- Decision date: 2010-08-24
Classification & Regulation
This clearance is catalogued under FDA product code OOK and 21 CFR 878.4340, within the General, Plastic Surgery review panel as a Class II device.