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Multi-modality skin surface treatment system

Access comprehensive regulatory information for Multi-modality skin surface treatment system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Ebos Medical Devices Australia Pty Ltd, manufactured by Ilooda Co Ltd in South Korea. The device registration started on March 31, 2016.

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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TGA ARTG Official Data
Class IIb
Class IIb
Multi-modality skin surface treatment system
Australia TGA ARTG Registered Device
Good Name: Ebos Medical Devices Australia Pty Ltd - Multi-modality skin surface treatment system
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Intended Purpose

The FRAXIS DUO system combines a fractional CO2 laser and micro-needle fractional RF for the treatment of acne scars, aging skin lesions and various skin renewal and rejuvenation applications, as well as hyperhidrosis, stress urinary incontinence and vaginal relaxation syndrome.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
March 31, 2016
Effective Date
March 31, 2016
Manufacturer
Country
South Korea
Address
9F 25 Deokcheon-ro 152beon-gil Manan-gu, Anyang-si, Gyeonggi-do, 14084