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Cryolipolysis skin contouring system

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.

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Class I
Class I
Cryolipolysis skin contouring system
Australia TGA ARTG Registered Device
Good Name: iinergy Pty Ltd - Cryolipolysis skin contouring system
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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.

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
Manufacturer
Country
China
Address
Room 201 2nd Floor Building 2 No 52 Hongsong Road High-tech Development Zone, Zhengzhou City, Henan Province, 450001