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Skin contouring system, radio-frequency - ARTG 445258

Access comprehensive regulatory information for Skin contouring system, radio-frequency in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 445258 and sponsored by MediCel Aesthetics, manufactured by Korea MCD Co Ltd in South Korea. The device registration started on April 04, 2024.

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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TGA ARTG Official Data
Class I
ARTG 445258
Class I
Skin contouring system, radio-frequency
ARTG ID: 445258
Good Name: MediCel Aesthetics - Skin contouring system, radio-frequency
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Intended Purpose

Device that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within body tissues to temporarily minimize the manifestation of cellulite, loose or wrinkled skin through a process of fat removal, skin regrowth and tightening, and the temporary relief of pain. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed in a controlled manner to produce the desired therapeutic effect whilst cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
445258
Start Date
April 04, 2024
Effective Date
April 04, 2024
Manufacturer
Country
South Korea
Address
805 Unitechvill 142 Ilsan-ro Ilsandong-gu, Goyang-shi, Gyeonggi-do