Australia TGA ARTG record

Thermal skin treatment system gel pad

Australia TGA ARTG Registered Device · Abbvie Pty Ltd · Zeltiq Aesthetics Inc · Class I · Started May 04, 2018

Good Name: Abbvie Pty Ltd - Thermal skin treatment system gel pad

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 04, 2018
Effective Date: May 04, 2018

Sponsor

Name: Abbvie Pty Ltd

Manufacturer

Name: Zeltiq Aesthetics Inc
Country: United States of America
Address: 4410 Rosewood Drive , Pleasanton, CA, 94588

Intended purpose

Thermal skin treatment system gel pad [56311] A non-sterile device designed to be applied to the skin of the patient to provide thermal coupling at the interface between the thermal skin treatment system applicator and the treatment site on the patient. It consists of a coupling gel in an envelope of thin material. This is a single-use device. Different styles/variants and packaging configurations will be available in the Australian market. May be provided as part of the Zeltiq Coolsculpt either with the initial system or in a repeat consumable order

About this record

Access comprehensive regulatory information for Thermal skin treatment system gel pad in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abbvie Pty Ltd, manufactured by Zeltiq Aesthetics Inc in United States of America. The device registration started on May 04, 2018.

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.