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Helios IV - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - ARTG 393512

Access comprehensive regulatory information for Helios IV - Dermatological Nd:YAG/frequency-doubled 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 393512 and sponsored by Laseraid International Pty Ltd, manufactured by Laseroptek Co Ltd in South Korea. The device registration started on August 05, 2022.

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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TGA ARTG Official Data
Class IIb
ARTG 393512
Class IIb
Helios IV - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
ARTG ID: 393512
Good Name: Laseraid International Pty Ltd - Helios IV - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
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Intended Purpose

Removal or lightening of unwanted hair, tattoo removal, treatment of vascular lesions, telangiectaias, spider angioma, cherry angioma, spider nevi, treatment of pigmented lesions.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
393512
Start Date
August 05, 2022
Effective Date
August 05, 2022
Manufacturer
Country
South Korea
Address
#114 #116 #117 #203 #204 Hyundai I Valley 31, Galmachi-ro 244beon-gil Jungwon-gu, Seongnam-si Gyeonggi-do, Korea, 13212