Intended purpose : The intended purpose of the device is to restore facial volume in order to correct moderate to severe midface volume deficit to treat signs of ageing.
Indication : The device is indicated to correct moderate to severe midface volume defi cit in the zygomaticomalar region, anteromedial cheek region and submalar region.
Injection area : Deep subcutaneous and/or supraperiosteal
Concentration HA : 2.5% (25mg/mL) high molecular weight hyaluronic acid of non-animal origin
Crosslinking agent : BDDE (concentration ≤ 2 ppm)
Additional ingredients : Phosphate buffer, NaCl, 0.3% lidocaine hydrochloride
Packaging unit : 1 box of 1mL syringe
Needle : 2×27G ½” thin wall TerumoTM needles (CE 0197)
Est. duration in the skin : Approximately 12 months