Device Dossier

Belotero Intense Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for Belotero Intense Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive…

Intended purpose

An injectable resorbable implant indicated to fill deep wrinkles and folds, as well as to restore and enhance soft tissue volume (e.g. contours of the face, lip volume etc.). It is also suitable for correction of facial atrophic scars. 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% lidocaine hydrochloride. Pack contains 2 sterile 27G1/2” needles.

TGA Public Summary