Australia TGA ARTG recordLEAF - Ophthalmic solid-state laser system, photocoagulation
Australia TGA ARTG Registered Device · Optimed Pty Ltd · Norlase ApS · Class IIb · Started March 24, 2023
Good Name: Optimed Pty Ltd - LEAF - Ophthalmic solid-state laser system, photocoagulation
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- March 24, 2023
- Effective Date
- March 24, 2023
- Name
- Optimed Pty Ltd
- Name
- Norlase ApS
- Country
- Denmark
- Address
- Brydehusvej 13, Ballerup, DK-2750
The LEAF and Echo are green laser delivery devices designed to be user-detachable from the Slit Lamp. LEAF and Echo is controlled via a wireless tablet user interface utilizing a touch screen or voice control of parameters. The Leaf may be used for all standard laser photocoagulation procedures and the Echo where pattern generating delivery is chosen.
Access comprehensive regulatory information for 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 Optimed Pty Ltd, manufactured by Norlase ApS in Denmark. The device registration started on March 24, 2023.
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.