Device Dossier
ARTFiller LIPS - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for ARTFiller LIPS - 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
ART FILLER® products are intended to restore changes to skin structure caused by ageing: fills in lines and creases in the facial skin, restores volume. LIPS filler is an injectable implant that is indicated to increase the volume and/or enhance the lip outline as well as to fill medium and deep nasolabial folds with or without marionette lines by injection into the middle to deep dermis. The inclusion of lidocaine aims to reduce 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 anaesthetic for patient comfort during treatment. The pack contains 4 needles and 2 pre-filled syringes of HA gel.