Australia TGA ARTG record

Focus Alger Brush II - Corneal bur handpiece, battery-powered

Australia TGA ARTG Registered Device · Faro Care Pty Ltd · Focus Ophthalmics LLC DBA Epsilon USA · Class I · Started April 12, 2017

Good Name: Faro Care Pty Ltd - Focus Alger Brush II - Corneal bur handpiece, battery-powered

Device classification

Risk Class: Class I
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: April 12, 2017
Effective Date: April 12, 2017

Sponsor

Name: Faro Care Pty Ltd

Manufacturer

Name: Focus Ophthalmics LLC DBA Epsilon USA
Country: United States of America
Address: 1215 W Holt Blvd Suit 200, Ontario, CA, 91762

Intended purpose

A battery-powered, hand-held slow rotating reusable device designed to perform corneal, and other ophthalmic tissue, abrasion through a bur attached to its distal tip. It is used (with appropriate burs/tips) to clean rust rings from the cornea after the extraction of a ferrous foreign object, to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions.

About this record

Access comprehensive regulatory information for Focus Alger Brush II - Corneal bur handpiece, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Faro Care Pty Ltd, manufactured by Focus Ophthalmics LLC DBA Epsilon USA in United States of America. The device registration started on April 12, 2017.

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.