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ZELTIQ system - Cryolipolysis skin contouring system - ARTG 476391

Access comprehensive regulatory information for ZELTIQ system - Cryolipolysis skin contouring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476391 and sponsored by Abbvie Pty Ltd, manufactured by Zeltiq Aesthetics Inc in United States of America. The device registration started on January 22, 2025.

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.

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Class IIb
ARTG 476391
Class IIb
ZELTIQ system - Cryolipolysis skin contouring system
ARTG ID: 476391
Good Name: Abbvie Pty Ltd - ZELTIQ system - Cryolipolysis skin contouring system
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Intended Purpose

The CoolSculptingยฎ System, also labeled as the ZELTIQยฎ System or the ZELTIQยฎ Breeze System (system), is a non-invasive cooling device that applies controlled cooling to a treatment site on the patientโ€™s skin. The device is intended to be used for fat layer reduction through cold-assisted lipolysis (breakdown of fat) for aesthetic purpose.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
476391
Start Date
January 22, 2025
Effective Date
January 22, 2025
Sponsor
Manufacturer
Country
United States of America
Address
4410 Rosewood Drive , Pleasanton, CA, 94588