Device Dossier
ZELTIQ system - Cryolipolysis skin contouring system
Device Dossier for ZELTIQ system - Cryolipolysis skin contouring system (Cryolipolysis skin contouring system, Class IIb, sponsor AbbVie). ARTG record,…
- GMDN category: Cryolipolysis skin contouring system
- Sponsor: AbbVie
Intended purpose
The CoolSculpting® System, also labeled as the ZELTIQ® System or the ZELTIQ® Breeze System (system), is a non-invasive cooling device that applies controlled cooling to a treatment site on the patient’s skin. The device is intended to be used for fat layer reduction through cold-assisted lipolysis (breakdown of fat) for aesthetic purpose.