Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Velocity 8 Pty Ltd - Surgical frequency-doubled Nd:YAG laser system
ARTG entry for
Medical Device Included Class IIb
Velocity 8 Pty Ltd
Level 4 / 257 Clarence 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.
Laseroptek Co Ltd
204 Hyundai l valley 31 Galmachi-ro
Seongnam-si, Gyeonggi-do, 13212
Korea - Republic of
1. Surgical frequency-doubled Nd:YAG laser system
Medical device system
36150 Surgical frequency-doubled Nd:YAG laser system
Dermatology laser for tattoo removal, treatment of pigmented lesions and treatment of other skin
conditions including psoriasis and vitiligo.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 02:58:36 AEDT
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