Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic

Australia - English - Department of Health (Therapeutic Goods Administration)

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Merz Australia Pty Ltd
Class III
Authorization status:
Authorization number:

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Public Summary

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

Postal Address

PO Box 209,Mascot,Sydney, NSW, 2020


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Anteis SA

18 Chemin des Aulx

Plan-Les-Ouates, , CH-1228



1. Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic

Product Type

Procedure Pack

Effective date



47887 Synthetic-fluid tissue reconstructive material, anaesthetic

Functional description

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.

Intended purpose

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.

Variant information

Nil variant (as 1 device) Not Applicable

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

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Produced at 03.11.2017 at 11:35:05 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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