Device Dossier
saypha filler Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for saypha filler Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
Intended purpose
The intended aesthetic purpose of saypha filler Lidocaine is to add volume. It is indicated to correct moderate to severe nasolabial folds and for lip augmentation, and must be injected injected into the mid to deep dermis or submucosa.
Functional description
The device is a sterile, biodegradable, viscoelastic, clear, transparent, isotonic and homogenized injectable gel implant which incorporates 0.3% lidocaine hydrochloride (medicinal substance). The ancillary role of lidocaine hydrochloride is to reduce the pain associated with injections into the skin.