Australia TGA ARTG record

Cryolipolysis skin contouring system

Australia TGA ARTG Registered Device · iinergy Pty Ltd · Zhengzhou PZ Laser Slim Technology Co Ltd · Class I · Started June 13, 2023

Good Name: iinergy Pty Ltd - Cryolipolysis skin contouring system

Device classification

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

Registration information

Start Date: June 13, 2023
Effective Date: June 13, 2023

Sponsor

Name: iinergy Pty Ltd

Manufacturer

Name: Zhengzhou PZ Laser Slim Technology Co Ltd
Country: China
Address: Room 201 2nd Floor Building 2 No 52 Hongsong Road High-tech Development Zone, Zhengzhou City, Henan Province, 450001

Intended purpose

This Cryolipolysis device is designed to non-invasively apply cold to the skin and subcutaneous tissues for subcutaneous fat layer reduction through cold assisted lipolysis for skin contouring. It primarily consists of a mains electricity control unit to produce cooling, and a handpiece which is used to convey and apply cold to the target areas. The device is not intended to cause weight loss or to treat obesity. The device is an active device not used for therapy or diagnosis.

About this record

Access comprehensive regulatory information for Cryolipolysis skin contouring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by iinergy Pty Ltd, manufactured by Zhengzhou PZ Laser Slim Technology Co Ltd in China. The device registration started on June 13, 2023.

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.