Summary for ARTG Entry:
Syneron Candela Corporation Australia Pty Ltd - Ultrasonic body-contouring system
ARTG entry for
Medical Device Included Class IIb
Syneron Candela Corporation Australia Pty Ltd
PO Box 252,PROSPECT, SA, 5082
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.
Syneron Medical Ltd
Industrial Zone Tavor Building
Yokneam Illit, , 20692
1. Ultrasonic body-contouring system
Single Device Product
45591 Ultrasonic body-contouring system
for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to
grow (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The use of
this system may serve as a noninvasive outpatient procedure alternative to liposuction.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:02:25 AEDT
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