Device Dossier
ARTFiller FINE LINES - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for ARTFiller FINE LINES - 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 ARTFiller FINE LINES filler is indicated to fill in fine lines, superficial lines and small skin folds of crow’s feet, forehead, upper lip and cheeks by means of an injection into the upper dermis. 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 facial 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 anaesthetic for patient comfort during treatment. The pack contains 4 needles and 2 pre-filled syringes of HA gel.