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E2 Compact Microprobe Laser and Endoscopy System - Endoscopic-imaging ophthalmic solid-state laser system

Access comprehensive regulatory information for E2 Compact Microprobe Laser and Endoscopy System - Endoscopic-imaging ophthalmic solid-state laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Beaver-Visitec International Australia Pty Ltd, manufactured by Beaver-Visitec International Inc in United States of America. The device registration started on April 24, 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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Class IIb
Class IIb
E2 Compact Microprobe Laser and Endoscopy System - Endoscopic-imaging ophthalmic solid-state laser system
Australia TGA ARTG Registered Device
Good Name: Beaver-Visitec International Australia Pty Ltd - E2 Compact Microprobe Laser and Endoscopy System - Endoscopic-imaging ophthalmic solid-state laser system
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Intended Purpose

The ophthalmic laser endoscope system, together with associated endoscopes and probes, is indicated for the intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do allow a posterior view. Also indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser cyclocryotherapy or other cyclodestuctive procedures.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 24, 2024
Effective Date
April 24, 2024
Manufacturer
Country
United States of America
Address
500 Totten Pond Road 10 CityPoint, Waltham, MA, 02451