Australia TGA ARTG record

Hyperthermia system, ultrasound

Australia TGA ARTG Registered Device · Soma Lasers Australia · GTG Wellness Co Ltd · Class IIa · Started September 17, 2021

Good Name: Soma Lasers Australia - Hyperthermia system, ultrasound

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: September 17, 2021
Effective Date: September 17, 2021

Sponsor

Name: Soma Lasers Australia

Manufacturer

Name: GTG Wellness Co Ltd
Country: South Korea
Address: A-1701-1704 902-904 Bundang Suji U-Tower 767 Sinsu-ro, Suji-gu Yonginsi, Gyeonggi-do, 16827

Intended purpose

Non invasive dermatological therapeutic device intended to be used for patients who have ptosis, psoriasis and for treatment of the wrinkle, tightening and lifting

About this record

Access comprehensive regulatory information for Hyperthermia system, ultrasound in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Soma Lasers Australia, manufactured by GTG Wellness Co Ltd in South Korea. The device registration started on September 17, 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.