Device Dossier

CoolSculpting Elite - Cryolipolysis skin contouring system

Device Dossier for CoolSculpting Elite - Cryolipolysis skin contouring system (Cryolipolysis skin contouring system, Class IIa, sponsor AbbVie). ARTG…

Intended purpose

The COOLSCULPTING® ELITE 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 the following medical purposes: * Fat layer reduction through cold-assisted lipolysis to reduce localised areas of fat * Skin cooling as a local anaesthetic for procedures that induce minor local discomfort * Minimising pain and thermal injury during laser and dermatological treatments. The device is not intended to cause weight loss or to treat obesity.

TGA Public Summary