Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Varicose vein lasing procedure kit
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
603 Queensbury Avenue
Queensbury, New York, 12804
United States Of America
1. Varicose vein lasing procedure kit
47535 Varicose vein lasing procedure kit
The devices are laser fibers in a procedure pack with other accessories indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of
varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and
for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should
be used only with lasers cleared for the use in treatment of varicose veins, varicosities with superficial
reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in
the lower limbs. In addition to the laser fiber, the procedure pack contains an entry needle, guidewire, and
No Specific Conditions included on Record
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