Device Dossier

Restylane Lyft Lidocane - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for Restylane Lyft Lidocane - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

Restylane Lyft Lidocaine is intended to be used for facial tissue augmentation. It is recommended to be used for shaping the contours of the face, the correction of folds and for lip enhancement. It should be injected into deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, or in the submucosal layer of the lip. For cheek augmentation, correction of age-related midface contour deficiencies and 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 Lyft Lidocaine is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid with addition of 0.3% lidocaine hydrochloride and is supplied in a glass syringe. Disposable 27G 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.

TGA Public Summary