Australia TGA ARTG recordIndirect binocular laser ophthalmoscope
Australia TGA ARTG Registered Device · Optimed Pty Ltd · Norlase ApS · Class IIb · Started March 24, 2023
Good Name: Optimed Pty Ltd - Indirect binocular laser ophthalmoscope
- 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 LION is a Laser Indirect Ophthalmoscope where the laser source is built into the headset, eliminating the need for an external laser console. LION is controlled via a wireless tablet user interface utilizing a touch screen or voice control of parameters. LION is powered by a rechargeable battery built into the foot switch. The device may be used for all standard single-shot photocoagulation procedures
Access comprehensive regulatory information for Indirect binocular laser ophthalmoscope 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.