Device Dossier

saypha volume Plus Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

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

Intended purpose

The intended aesthetic purpose of saypha volume Plus Lidocaine the device is to restore facial volume. It is indicated to correct moderate to severe midface volume defecit. It must be administered by deep subcutaneous and/or supraperiosteal injection.

Functional description

saypha volume Plus Lidocaine is a sterile, biodegradable, viscoelastic, clear, transparent, isotonic and homogenized injectable gel implant. The device is intended for single use, it is non-active and without measuring function. A drug substance (Lidocaine Hydrochloride) is integrated into the device. The ancillary role of Lidocaine Hydrochloride is to reduce the pain associated with injections into the patient.

TGA Public Summary