Pure Global

Skin contouring system, multifunction

Access comprehensive regulatory information for Skin contouring system, multifunction 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 September 12, 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
Skin contouring system, multifunction
Australia TGA ARTG Registered Device
Good Name: MediCel Aesthetics - Skin contouring system, multifunction
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Intended Purpose

This device uses Radio Frequency energy and Ultrasound to generate heat deep within body tissues to minimize the manifestation lose or wrinkled skin promoting skin tightening. It is indicated for use for Treating Axillary Hyperhidrosis.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
September 12, 2023
Effective Date
September 12, 2023
Manufacturer
Country
South Korea
Address
805 Unitechvill 142 Ilsan-ro Ilsandong-gu, Goyang-shi, Gyeonggi-do