Device Dossier
ARTFiller VOLUME - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for ARTFiller VOLUME - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
- Sponsor: Ebos Medical Devices
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 VOLUME filler is indicated to restore volume to the mid-face, temples, jawline and chin via subcutaneous, supraperiostal or deep dermis injections. 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. Pack contains 2 pre-filled syringes and 4 needles.