Device Dossier
Revanesse Ultra+ - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Revanesse Ultra+ - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Taevas Life Sciences
Intended purpose
Medical Indications: The products are space-occupying tissue reconstructive materials composed of a hyaluronic acid gel that is indicated for restoration of volume lost from lipoatrophy/lipodystrophy, and/or correction of contour deficiencies and anatomic deformities of either pathologic origin or after trauma, in facial soft tissue. Intended patients are those desiring the correction of contour deficiencies and deformities in facial soft tissue, such as HIV-associated lipoatrophy and lipodystrophy. Cosmetic Indication: Revanesse® Ultra™+ is indicated for the treatment of facial rhytides, volume restoration, lip augmentation, skin hydration and contouring of depressions by injection into tissue.
Functional description
The Revanesse® Ultra+ with Lidocaine are injected by qualified, trained physicians into the dermis of patients, using a variety of techniques. The injections place a small portion of the gel beneath a crease or wrinkle in the skin and the augmentation of the tissue produces a smoothing effect on the surface. The Revanesse® Ultra+ fillers are designed so that there is minimal migration and no need for volume corrections with a follow-up procedure.