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Ellisys Plus Fractional RF System with Sterile Microneedles - Electrosurgical system, general-purpose

Australia TGA ARTG Registered Device · SkinMed Australia Pty Ltd · Chungwoo Co Ltd · Class IIb · Started June 27, 2024

Good Name: SkinMed Australia Pty Ltd - Ellisys Plus Fractional RF System with Sterile Microneedles - Electrosurgical system, general-purpose

Device classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration information
Start Date
June 27, 2024
Effective Date
June 27, 2024
Sponsor
Manufacturer
Country
South Korea
Address
(Gasan-dong Woolim lionsvally-2) 614 2 Gasandigital1-ro Geumcheon-gu, Seoul, 08591
Intended purpose

This device is a Fractional RF unit with sterile micro needles which is designed for applying radio frequency therapy with microneedles. It is intended to use for dermal coagulation to the tissue by using bipolar technique without a neutral electrode, for the treatment of such conditions as deep wrinkles, skin rejuvenation and acne scaring.

About this record

Access comprehensive regulatory information for Ellisys Plus Fractional RF System with Sterile Microneedles - Electrosurgical system, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by SkinMed Australia Pty Ltd, manufactured by Chungwoo Co Ltd in South Korea. The device registration started on June 27, 2024.

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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