Device Dossier
RESTYLANE CLASSYC LIDOCAINE - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for RESTYLANE CLASSYC LIDOCAINE - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Galderma
Intended purpose
Restylane Lidocaine is intended to be used for facial tissue augmentation. It is recommended to be used for the correction of wrinkles and for lip enhancement. It should be injected into the middle part of the dermis layer or in the submucosal layer of the lip. For facial areas with limited soft tissue support and soft tissue cover, e.g. the periorbital region, injection into the subcutaneous fatty tissue or supraperiostal administration are recommended. The addition of lidocaine provides a pain relieving effect during treatment.
Functional description
Restylane Lidocaine is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid with the addition of 0.3% lidocaine hydrochloride and is supplied in a glass syringe and disposable 29G thin wall needles are provided with the device. The device is a filler that adds volume to the tissue, thereby restoring the skin contours or enhancing the lips to the desired level of correction. The volume and lifting capacity originate from the ability of stabilized hyaluronic acid to bind water.