Device Dossier
Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Merz
Intended purpose
Belotero® Lips Shape is an injectable resorbable implant indicated to correct facial atrophic scars and to enhance soft tissue volume (e.g. lip volume, severe 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 with gel and 2 sterile 27G 1/2" needles.