Device Dossier
Princess Volume Plus Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Princess Volume Plus Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Hugel
Intended purpose
The intended purpose of the device is to restore facial volume in order to correct moderate to severe midface volume deficit to treat signs of ageing.
Functional description
Princess 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.