Summary for ARTG Entry:
Getz Healthcare Pty Ltd - Laser delivery unit, fibreoptic
ARTG entry for
Medical Device Included Class IIa
Getz Healthcare Pty Ltd
5 Orion Road,LANE COVE, NSW, 2066
ARTG Start Date
Medical Device Class IIa
- 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.
LightGuideOptics Germany GmbH
1. Laser delivery unit, fibreoptic
Single Device Product
36185 Laser delivery unit, fibreoptic
A flexible, sterile and single-use fibreoptic cable intended for the delivery of laser energy of visible and
near-infrared wavelengths. It delivers the laser energy from the laser generator to the target site. It is
designed to be used in endovascular laser ablation procedures of the vena saphena magna and vena
saphena parva for patients with venous insufficiency.
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.
Page 1 of
Produced at 09.11.2017 at 10:49:32 AEDT
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