Device Dossier
– ZELTIQ System - Cryolipolysis skin contouring system
Device Dossier for – ZELTIQ System - Cryolipolysis skin contouring system (Cryolipolysis skin contouring system, Class IIa, sponsor AbbVie). ARTG record,…
- GMDN category: Cryolipolysis skin contouring system
- Sponsor: AbbVie
Intended purpose
The ZELTIQ™ 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 to reduce localized areas of fat. The device is not intended to cause weight loss or to treat obesity.