Australia TGA ARTG record

Skin contouring system, radio-frequency

Australia TGA ARTG Registered Device · Classys Australia Pty Ltd · Classys Inc · Class IIb · Started June 11, 2024

Good Name: Classys Australia Pty Ltd - Skin contouring system, radio-frequency

Device classification

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

Registration information

Start Date: June 11, 2024
Effective Date: June 11, 2024

Sponsor

Name: Classys Australia Pty Ltd

Manufacturer

Name: Classys Inc
Country: South Korea
Address: CLASSYS 208 Teheran-ro Gangnam-gu, Seoul

Intended purpose

Volnewmer is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue, and non-invasive treatment of wrinkles and rhytids

About this record

Access comprehensive regulatory information for Skin contouring system, radio-frequency in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Classys Australia Pty Ltd, manufactured by Classys Inc in South Korea. The device registration started on June 11, 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.