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Indirect binocular laser ophthalmoscope

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.

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Class IIb
Class IIb
Indirect binocular laser ophthalmoscope
Australia TGA ARTG Registered Device
Good Name: Optimed Pty Ltd - Indirect binocular laser ophthalmoscope
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Intended Purpose

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

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
March 24, 2023
Effective Date
March 24, 2023
Sponsor
Manufacturer
Country
Denmark
Address
Brydehusvej 13, Ballerup, DK-2750