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Cryolipolysis skin contouring system - ARTG 353565

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 IIa is registered under ARTG number 353565 and sponsored by MediCel Aesthetics, manufactured by Hironic Co Ltd in South Korea. The device registration started on January 25, 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.

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Class IIa
ARTG 353565
Class IIa
Cryolipolysis skin contouring system
ARTG ID: 353565
Good Name: MediCel Aesthetics - Cryolipolysis skin contouring system
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Intended Purpose

To provide cooling therapy cryolipolysis for the reduction of subcutaneous fat. This device reduces the fat layer thickness by cooling the fat cells. Including treatment of Psuedogynecomastia and metabolization of those fat cells.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
353565
Start Date
January 25, 2021
Effective Date
January 25, 2021
Manufacturer
Country
South Korea
Address
19F 767 Sinsu-ro Suji-gu Yongin-si, Gyeonggi-do, 16827