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Surgical diode laser system - ARTG 392412

Access comprehensive regulatory information for 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 392412 and sponsored by MEDISOL PTY LTD, manufactured by Wuhan Gigaa Optronics Technology Co Ltd in China. The device registration started on July 18, 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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Class IIb
ARTG 392412
Class IIb
Surgical diode laser system
ARTG ID: 392412
Good Name: MEDISOL PTY LTD - Surgical diode laser system
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Intended Purpose

The Gigaa diode laser generators are indicated for emitting energy in the infrared spectrum to cut, excise, vaporize, and coagulate tissues in various surgical applications such as oral soft-tissue (gingivectomy) and general surgery (lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression(PLDD), ear/nose/throat ENT interventions and benign prostatic hyperplasia (BPH) therapy.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
392412
Start Date
July 18, 2022
Effective Date
July 18, 2022
Sponsor
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