Device Dossier
CoolSculpting Elite - Cryolipolysis skin contouring system
Device Dossier for CoolSculpting Elite - Cryolipolysis skin contouring system (Cryolipolysis skin contouring system, Class IIb, sponsor AbbVie). ARTG…
- GMDN category: Cryolipolysis skin contouring system
- Sponsor: AbbVie
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 fat layer reduction through cold-assisted lipolysis for aesthetic purposes.