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Surgical Diode Laser System - Surgical diode laser system - ARTG 304895

Access comprehensive regulatory information for Surgical Diode Laser System - Surgical 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 304895 and sponsored by Dental Premium Engineering & Supplies, manufactured by Wuhan Gigaa Optronics Technology Co Ltd in China. The device registration started on June 21, 2018.

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 304895
Class IIb
Surgical Diode Laser System - Surgical diode laser system
ARTG ID: 304895
Good Name: Dental Premium Engineering & Supplies - Surgical Diode Laser System - Surgical diode laser system
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DJ Fang

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Intended Purpose

The DIODE laser system emits light energy in the infrared spectrum to cut, excise, vaporize, and coagulate tissues in various surgical applications such as Oral/Dental procedures and general surgery ,lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression(PLDD), ear/nose/throat ENT interventions and physio/podiatry therapy.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
304895
Start Date
June 21, 2018
Effective Date
June 21, 2018
Manufacturer
Country
China
Address
5 6/F Unit A B Building B8 Hi-Tech Medical Device Industrial Park 818 Gaoxin Ave, East Lake Development Zone, Wuhan, 430206