Device Dossier
ARTFiller LIPS SOFT - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for ARTFiller LIPS SOFT - 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 LIPS SOFT filler is an injectable implant indicated to increase the volume of the lip and enhance the lip outline and to fill medium and deep naso-labial folds with or without marionette lines by injection into the middle to deep dermis. The Filler contains Lidocaine to reduce any painful sensations for the patient during treatment.
Functional description
Cross-linked Hyaluronic acid-phosphate buffer gel implant that physically corrects structural changes of the skin and lips associated with aging, having a plumping effect on naso-labial folds and increases volume of lips with enhanced lip outline, 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 one pre-filled syringe of HA gel and 2 sterile needles.