Australia TGA ARTG record

Surgical Diode Laser System - Surgical diode laser system

Australia TGA ARTG Registered Device · Dental Premium Engineering & Supplies · Wuhan Gigaa Optronics Technology Co Ltd · Class IIb · Started June 21, 2018

Good Name: Dental Premium Engineering & Supplies - Surgical Diode Laser System - Surgical diode laser system

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: June 21, 2018
Effective Date: June 21, 2018

Sponsor

Name: Dental Premium Engineering & Supplies

Manufacturer

Name: Wuhan Gigaa Optronics Technology Co Ltd
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

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.

About this record

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 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.