Device Dossier

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

Device Dossier for Belotero Lips Contour - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

Belotero Lips Contour is an injectable resorbable implant indicated to correct facial atrophic scars and for lip enhancement (e.g. lip contour, perioral fine lines, moderate oral commissures). The presence of lidocaine aims to reduce local pain associated with the injection of the gel and to improve patient comfort.

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, 1 sterile 27G 1/2" needle and 1 sterile 30G 1/2" needle.

TGA Public Summary