Ophthalmic surgical systems - Cataract extraction/vitrectomy system

Public Summary

Summary for ARTG Entry:

339429

Device Technologies Australia Pty Ltd - Ophthalmic surgical systems - Cataract extraction/vitrectomy

system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521, FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

13/07/2020

Product Category

Medical Device Class IIb

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

Oertli Instrumente AG

Hafnerwisenstrasse 4

Berneck, Switzerland, 9442

Switzerland

Products

1 . Ophthalmic surgical systems - Cataract extraction/vitrectomy system

Product Type

Medical device system

Effective Date

13/07/2020

GMDN

45072 Cataract extraction/vitrectomy system

Intended Purpose

An ophthalmic surgical system intended to be used for phacoemulsification and vitrectomy procedures in the anterior and/or

posterior segments of the eye.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 09:30:44 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information