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Healite II - Phototherapy unit, red light, line-powered - ARTG 426411

Access comprehensive regulatory information for Healite II - Phototherapy unit, red light, line-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 426411 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 426411
Class IIb
Healite II - Phototherapy unit, red light, line-powered
ARTG ID: 426411
Good Name: Ebos Medical Devices Australia Pty Ltd - Healite II - Phototherapy unit, red light, line-powered
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Intended Purpose

Healite II is a high-performance LED, LLLT (Low-Level Light Therapy) system designed to photomodulate cellular function, improving healing times, relieving pain, subsiding active acne, promoting skin rejuvenation andother.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
426411
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