Device Dossier

Neauvia Intense Lips - Dermal tissue reconstructive material, microbe-derived

Device Dossier for Neauvia Intense Lips - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material, microbe-derived,…

Intended purpose

Medical device indicated for the temporary correction of the sign of primary soft tissue senile atrophy of the face in adults (over 26 years old), women (not pregnant or breastfeeding) and men.

Functional description

A biodegradable crosslinked Hyaluronic Acid hydrogel enriched with Glycine and L-Proline in phosphate buffer solution. The device is a sterile, non-pyrogenic, injectable hydrogel. The device is supplied in pre-filled 1.0 ml disposable syringes with a luer-lock connection to be injected into the vermillium and/or perioral area.

TGA Public Summary