Device Dossier

Teosyal RHA 1 - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for Teosyal RHA 1 - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

Indicated for the even filling of lines, superficial wrinkles, fine wrinkles and skin cracks, and for the correction of areas of skin that are wizened or marked by signs of ageing on the face. It is also indicated for filling wrinkles and skin folds (including circles under the eyes.)

Functional description

A visco-elastic gel of both cross-linked and non-modified hyaluronic acid of non- animal origin. The gel is sterile, non-pyrogenic, transparent and contains 0.3% by mass of lidocaine hydrochloride, for its anaesthetic properties. Provided in prefilled syringes, with needles, for dermal injection.

TGA Public Summary