Device Dossier
REVOLAX™ DEEP with Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for REVOLAX™ DEEP with Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Hugel
Intended purpose
REVOLAX™ DEEP with Lidocaine (containing 27Gx1/2” needle gauge) is intended for intradermal implantation to facial volume loss as well as for facial morphological asymmetry.
Functional description
REVOLAX™ DEEP with Lidocaine is a sterile pyrogen-free physiological gel of cross-linked hyaluronic acid of non-animal origin with the addition of 0.3% lidocaine hydrochloride. It is a colorless, odorless and highly viscous aqueous gel. REVOLAX™ DEEP with Lidocaine is presented as one sterile 1.1mL volume in a single-use syringe along with two sterilized needles.