Device Dossier

SkinVive by Juvederm - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for SkinVive by Juvederm - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

• SkinVive by Juvéderm® is an injectable implant used for the treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity, via intradermal injection. • The presence of lidocaine is meant to to reduce the patient’s pain during treatment.

Functional description

SkinVive by Juvéderm® is a sterile pyrogenfree physiological solution of cross-linked hyaluronic acid gel presented in a graduated, pre-filled, disposable syringe. 2 syringes with 4 32G 1/2 inch needles are provided in a box along with traceability labels and the DFU. SkinVive by Juvéderm® is used for the treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attribute such as hydration and elasticity.

TGA Public Summary