Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Merz Australia Pty Ltd - Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic
ARTG entry for
Medical Device Included Class III
Merz Australia Pty Ltd
PO Box 209,Mascot,Sydney, NSW, 2020
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.
18 Chemin des Aulx
Plan-Les-Ouates, , CH-1228
1. Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic
47887 Synthetic-fluid tissue reconstructive material, anaesthetic
A sterile, non-pyrogenic, viscoelastic, colourless, transparent cross-linked sodium hyaluronate gel of
non-animal origin in a physiological phosphate buffer. Contains 0.3% of lidocaine hydrochloride. Pack
contains 1 sterile 0.6mL syringe with gel and 2 sterile 27G 1/2" needles.
Belotero® Lips Shape is an injectable resorbable implant indicated to correct facial atrophic scars and to
enhance soft tissue volume (e.g. lip volume, severe oral commissures). The presence of lidocaine aims to
reduce local pain associated with the injection of the gel and to improve patient comfort.
Nil variant (as 1 device) Not Applicable
No Specific Conditions included on Record
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