K233732
- 510(k) number
- K233732
- Device name
- CoolSculpting Elite System
- Applicant
- Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics CA · US
- Product code
- OOK — Dermal Cooling Pack/Vacuum/Massager
- Decision date
- 2024-09-12
- Date received
- 2023-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233732.pdf
Official FDA record: K233732
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.