CoolSculpting Elite - Cryolipolysis skin contouring system
Access comprehensive regulatory information for CoolSculpting Elite - Cryolipolysis skin contouring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Abbvie Pty Ltd, manufactured by Zeltiq Aesthetics Inc in United States of America. The device registration started on July 28, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.