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Ophthalmic laser system beam guide

ARTG ID: 460288 · Kevin Grundy (IBD) Pty Ltd · Vortex Surgical Inc · Class IIa · Started August 21, 2024

Good Name: Kevin Grundy (IBD) Pty Ltd - Ophthalmic laser system beam guide

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
460288
Start Date
August 21, 2024
Effective Date
August 21, 2024
Sponsor
Manufacturer
Country
United States of America
Address
4 Research Park Drive Suite 124, St Charles, Missouri, 63304
Intended purpose

Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.

About this record

Access comprehensive regulatory information for Ophthalmic laser system beam guide in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 460288 and sponsored by Kevin Grundy (IBD) Pty Ltd, manufactured by Vortex Surgical Inc in United States of America. The device registration started on August 21, 2024.

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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