Device Dossier

saypha lips Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for saypha lips Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

The intended aesthetic purpose of saypha lips 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.

TGA Public Summary