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Clarity II & Clarity II LPA - Dermatological Nd:YAG laser system - ARTG 426430

Access comprehensive regulatory information for Clarity II & Clarity II LPA - 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 426430 and sponsored by Ebos Medical Devices Australia Pty Ltd, manufactured by Lutronic Corporation in South Korea. The device registration started on October 20, 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 426430
Class IIb
Clarity II & Clarity II LPA - Dermatological Nd:YAG laser system
ARTG ID: 426430
Good Name: Ebos Medical Devices Australia Pty Ltd - Clarity II & Clarity II LPA - Dermatological Nd:YAG laser system
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Intended Purpose

The ND:YAG(1064nm) wavelength of Clarity II is intended for use in the treatment to reduce the papule of Pseudofollicular barbae and to improve the port wine stain. The Alexandrite(755nm) wavelength of Clarity II and Clarity II LPA is intended for use in the treatment to reduce the papule of Pseudofollicular barbae, to improve the port wine stain and to remove the congenical melancytic Nevus.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
426430
Start Date
October 20, 2023
Effective Date
October 20, 2023
Manufacturer
Country
South Korea
Address
Lutronic Center 219 Sowon-ro Deogyang-gu, Goyang-si, Gyeonggi-do