Australia TGA ARTG record

LeShape - Skin contouring system, multifunction

Australia TGA ARTG Registered Device · Soma Lasers Australia · GTG Wellness Co Ltd · Class IIb · Started February 13, 2023

Good Name: Soma Lasers Australia - LeShape - Skin contouring system, multifunction

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: February 13, 2023
Effective Date: February 13, 2023

Sponsor

Name: Soma Lasers Australia

Manufacturer

Name: GTG Wellness Co Ltd
Country: South Korea
Address: A-902-904 Bundang Suji U-Tower 767 Sinsu-ro Suji-gu, Yongin-si, Gyeonggi-do, 16827

Intended purpose

Noninvasive multi-modality skin contouring system consisting of energy-producing generator, applicators and other components, intended to be used for treatments to temporarily minimise cellulite, wrinkled skin and loose skin.

About this record

Access comprehensive regulatory information for LeShape - 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 Soma Lasers Australia, manufactured by GTG Wellness Co Ltd in South Korea. The device registration started on February 13, 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.