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Norlase Leaf - Ophthalmic solid-state laser system, photocoagulation

Access comprehensive regulatory information for Norlase Leaf - Ophthalmic solid-state laser system, photocoagulation in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Titan Healthcare Pty Ltd, manufactured by Norlase ApS in Denmark. The device registration started on October 30, 2020.

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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TGA ARTG Official Data
Class IIb
Class IIb
Norlase Leaf - Ophthalmic solid-state laser system, photocoagulation
Australia TGA ARTG Registered Device
Good Name: Titan Healthcare Pty Ltd - Norlase Leaf - Ophthalmic solid-state laser system, photocoagulation
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Intended Purpose

The Norlase Leaf Photocoagulator is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
October 30, 2020
Effective Date
October 30, 2020
Manufacturer
Country
Denmark
Address
Brydehusvej 13, Ballerup, DK-2750