Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Nail photodynamic therapy kit
ARTG entry for
Medical Device Included Class IIb
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 IIb
- 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.
11 Ilahee Lane
Chico, CA, 95973
United States Of America
1. Nail photodynamic therapy kit
Medical device system
60383 Nail photodynamic therapy kit
The laser and its delivery devices are intended to be used in the medical specialty of podiatry (ablation,
vaporization, incision, excision, and coagulation of soft tissue from the knee to the foot). The laser is
specifically intended for the increase of clear nail in patients with onychomycosis (e.g., dermatophytes
Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:32:54 AEDT
This is not an ARTG Certificate document.
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