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Diode Laser Therapy Systems - Hair-removal diode laser system - ARTG 459806

Access comprehensive regulatory information for Diode Laser Therapy Systems - Hair-removal diode 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 459806 and sponsored by Freyr Australia Pty Ltd, manufactured by BEIJING UNT Technology Co Ltd in China. The device registration started on August 16, 2024.

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 459806
Class IIb
Diode Laser Therapy Systems - Hair-removal diode laser system
ARTG ID: 459806
Good Name: Freyr Australia Pty Ltd - Diode Laser Therapy Systems - Hair-removal diode laser system
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Intended Purpose

The Diode laser therapy system is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
459806
Start Date
August 16, 2024
Effective Date
August 16, 2024
Manufacturer
Country
China
Address
M2-1 Area Xinggu Development Zone, Pinggu District, Beijing, 101200