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DermaV - Dermatological Nd:YAG laser system - ARTG 427496

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 registered under ARTG number 427496 and 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.

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Class IIb
ARTG 427496
Class IIb
DermaV - Dermatological Nd:YAG laser system
ARTG ID: 427496
Good Name: Ebos Medical Devices Australia Pty Ltd - DermaV - Dermatological Nd:YAG laser system
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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

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
427496
Start Date
November 07, 2023
Effective Date
November 07, 2023
Manufacturer
Country
South Korea
Address
Lutronic Center 219 Sowon-ro Deogyang-gu, Goyang-si, Gyeonggi-do