Device Dossier

ARTFiller UNIVERSAL - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for ARTFiller UNIVERSAL - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

The ARTFiller range is intended to restore changes to skin structure caused by ageing: fills in lines and creases in the facial skin, restores volume.The UNIVERSAL filler is indicated to fill medium and deep naso-labial folds with or without marionette lines by injection into the middle to deep dermis and to increase the volume of the lip and enhance the lip outline. The Filler contains Lidocaine to reduce any painful sensations for the patient during treatment.

Functional description

Cross-linked Hyaluronic acid-phosphate buffer gel injected under the skin physically corrects structural changes of the skin associated with aging, having a plumping/volume restoration effect to reduce facial wrinkles and skin folds, until degraded naturally by the body over several months. The lidocaine in the formulation acts as a short-term local anaesthetic for patient comfort during treatment. The Pack contains 2 pre-filled syringes of HA gel and 4 needles.

TGA Public Summary