Device Dossier
Belotero Volume Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Belotero Volume Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Merz
Intended purpose
Belotero Volume Lidocaine is an injectable resorbable implant indicated to restore facial volumes, as for example to enhance the cheeks or the chin. 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 1ml syringes of gel, 2 sterile 27G1/2” needles, 2 sterile 30G 1/2” needles, 2 27G cannulae and 2 pre-hole needles.