Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Australasian Medical & Scientific Ltd - Stylage S Lidocaine - Synthetic-fluid tissue reconstructive material,
ARTG entry for
Medical Device Included Class III
Australasian Medical & Scientific Ltd
PO Box 5197,WEST CHATSWOOD, NSW, 1515
ARTG Start Date
Medical Device Class III
- 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.
252 Rue Douglas Engelbart Archamps
, Archamps, 74160
1. Stylage S Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Single Device Product
47887 Synthetic-fluid tissue reconstructive material, anaesthetic
Sterile, cross-linked hyaluronic acid gel with physiological pH and osmolarity, which incorporates a
medicinal substance (Lidocaine Hydrochloride). When injected, the device generates volume by filling in
the treatment area and is reabsorbed over time. The device is packed in a 0.8mL pre-filled syringe. The
ancillary role of Lidocaine Hydrochloride is to reduce pain associated with injections into the skin.
Stylage® S lidocaïne is an injectable hyaluronic acid gel, intended to fill in facial skin depression (i.e.
treatment of nasolabial folds) by injection into the dermis, by a skilled legally qualified practitioner trained in
techniques for injecting implants.
The lidocaine hydrochloride is intended to reduce pain linked to the injection.
Nil variant (as 1 device) Not Applicable
No Specific Conditions included on Record
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Produced at 01.12.2017 at 09:23:41 AEDT
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