Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Velocity 8 Pty Ltd - SMARTLUX - Cosmetic phototherapy system, professional
ARTG entry for
Medical Device Included Class IIa
Velocity 8 Pty Ltd
Level 4 / 257 Clarence 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.
Medmix Co Ltd
B-707 Smartvalley 30 Songdomirae-ro
Yeonsu-gu, Incheon, 406-840
Korea - Republic of
1. SMARTLUX - Cosmetic phototherapy system, professional
Medical device system
47705 Cosmetic phototherapy system, professional
A medical device which emits energy for the treatment of the skin surface for various conditions and the
temporary relief of pain.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:48:13 AEDT
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