Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Syneron Candela Corporation Australia Pty Ltd - Skin surface treatment system applicator, laser
ARTG entry for
Medical Device Included Class IIa
Syneron Candela Corporation Australia Pty Ltd
PO Box 252,PROSPECT, SA, 5082
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.
Syneron Medical Ltd
PO Box 550 Industrial Zone Tavor Building
, Yokneam Illit, 2069200
1. Skin surface treatment system applicator, laser
Single Device Product
45221 Skin surface treatment system applicator, laser
A hand-piece that is part of a system intended for the treatment of vulvovaginal atrophy (VVA) and vaginal
rejuvenation. This is a single use device.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:19:42 AEDT
This is not an ARTG Certificate document.
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