Device Dossier

Monalisa Lidocaine Dermal Filler - Hard Type - Dermal tissue reconstructive material, microbe-derived

Device Dossier for Monalisa Lidocaine Dermal Filler - Hard Type - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive…

Intended purpose

Monalisa Lidocaine Dermal Filler - Hard Type is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds and contain the local anaesthetic lidocaine for a more comfortable injection in patient over the age 21. It is a sterile injectable 1mL pre-filled syringes containing hyaluronic acid and lidocaine gel.

Functional description

Monalisa Lidocaine Dermal Filler - Hard Type is Sterile, cross-linked hyaluronic acid gel with non-pyrogenic properties for the correction of moderate to severe facial wrinkles and folds. When injected, the device generates volume by filling in the treatment area and is reabsorbed over time. The device is packed in a 1mL pre-filled syringe.

TGA Public Summary