Device Dossier
Restylane Skinboosters Vital Light Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Restylane Skinboosters Vital Light Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Galderma
Intended purpose
Restylane Skinboosters Vital Light Lidocaine is intended to restore skin hydrobalance, improve skin structure and the elasticity of the skin. It should be injected in the dermal layer of the skin, preferably in the deeper part of dermis. The addition of lidocaine provides increased overall treatment comfort.
Functional description
The device is a sterile transparent gel of 12mg/ml of stabilized hyaluronic acid with the addition of 0.3% lidocaine hydrochloride which is supplied in a glass syringe. It has a built in dose guide, smart click system that when activated creates a clicking sound to indicate each injected dose. The device comes in a 1ml syringe which can give up to approximately 100 doses.