Device Dossier

Juvederm Ultra XC - Tissue reconstructive material, biological

Device Dossier for Juvederm Ultra XC - Tissue reconstructive material, biological (Biological tissue reconstructive material, Class III, sponsor AbbVie).…

Intended purpose

Indicated for filling any medium-sized depressions of skin via mid-dermis injection, as well as lip definition and pouting of lips. The presence of lidocaine is meant to reduce patients pain during the treatment.

Functional description

It is a sterile, non-pyrogenic, physiological solution of cross-linked hyaluronic acid. The gel is presented in a graduated, pre-filled disposable syringe. it contains 3mg/mL lidocaine.

TGA Public Summary