Device Dossier
Belotero Balance Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Belotero Balance Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Merz
Intended purpose
An injectable resorbable filler implant indicated to fill moderate facial wrinkles and folds as well as for lip enhancement. It is also suitable for correction of facial atrophic scars. The presence of lidocaine reduces local pain associated to the injection of the gel and improves patient’s comfort during and immediately after injection.
Functional description
A sterile, non-pyrogenic, viscoelastic, colourless, transparent cross-linked sodium hyaluronate gel of non-animal origin, in a physiological buffer. Contains 0.3% lidocaine hydrochloride. Pack contains 1 sterile 1.0mL syringe, 1 sterile 27G½” needle and 1 sterile 30G½” needle.