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 IIb is sponsored by MediCel Aesthetics, manufactured by Hironic Co Ltd in South Korea. The device registration started on February 22, 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 IIb
Class IIb
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 loose or wrinkled skin promoting skin tightening. It is indicated for use for Treating Axillary Hyperhidrosis.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 22, 2021
Effective Date
February 22, 2021
Manufacturer
Country
South Korea
Address
19F 767 Sinsu-ro Suji-gu Yongin-si, Gyeonggi-do, 16827