Pure Global

Laser, software

Access comprehensive regulatory information for Laser, software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Gal Holdings SA Pty Ltd, manufactured by IVIS Technologies Srl in Italy. The device registration started on December 14, 2010.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
Class IIb
Laser, software
Australia TGA ARTG Registered Device
Good Name: Gal Holdings SA Pty Ltd - Laser, software
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Corneal Interactive Topographic Software together with Corneal Lamellar Ablation for Transplantation Software for use with iRES Excimer Laser Surgery System. This software customises laser surgeries for ophthalmic excimer laser systems. The interactive topographic software incorporates a synthesis of refractive high definition elevation and pupillometry data to deliver custom refractive surgery. The Lamellar Ablation software creates a uniform thickness corneal bed before corneal surgery.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
December 14, 2010
Effective Date
December 14, 2010
Manufacturer
Country
Italy
Address
Via Luigi Corsi 50, Taranto, 74100