Device Dossier
Belotero Soft Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Belotero Soft Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Merz
Intended purpose
Belotero Soft Lidocaine is an injectable resorbable implant indicated to fill fine facial lines and wrinkles as well as for lip enhancement. It is also suitable for the 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% of lidocaine hydrochloride. Pack contains 1 sterile single use 1mL syringe of gel and 2 sterile 30G 1/2" needles.