Australia flagAustralia TGA ARTG record

DermaV - Dermatological Nd:YAG laser system

Australia TGA ARTG Registered Device · Ebos Medical Devices Australia Pty Ltd · Lutronic Corporation · Class IIb · Started November 07, 2023

Good Name: Ebos Medical Devices Australia Pty Ltd - DermaV - Dermatological Nd:YAG laser system

Device classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration information
Start Date
November 07, 2023
Effective Date
November 07, 2023
Sponsor
Manufacturer
Country
South Korea
Address
Lutronic Center 219 Sowon-ro Deogyang-gu, Goyang-si, Gyeonggi-do
Intended purpose

DermaV is intended for use in the medical specialty of dermatology requiring selective photothermolysis of target chromophores in soft tissue. The 532 nm wavelength is intended to be used by a trained physician as treatment of the following: -Benign vascular lesions, including Spider veins of the lower extremities - Benign cutaneous lesions, including Erythematous scars The 1064 nm wavelength is intended to be used by a trained physician as treatment of the following: - Benign vascular lesions, including Port wine stains

About this record

Access comprehensive regulatory information for DermaV - Dermatological Nd:YAG laser 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 Lutronic Corporation in South Korea. The device registration started on November 07, 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.

Free DatabasePowered by Pure Global AITGA ARTG Official Data