Australia TGA ARTG record

Skin contouring system, radio-frequency

Australia TGA ARTG Registered Device · MediCel Aesthetics · Korea MCD Co Ltd · Class I · Started April 04, 2024

Good Name: MediCel Aesthetics - Skin contouring system, radio-frequency

Device classification

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

Registration information

Start Date: April 04, 2024
Effective Date: April 04, 2024

Sponsor

Name: MediCel Aesthetics

Manufacturer

Name: Korea MCD Co Ltd
Country: South Korea
Address: 805 Unitechvill 142 Ilsan-ro Ilsandong-gu, Goyang-shi, Gyeonggi-do

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.

About this record

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 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.