Device Dossier

My Skin Chemistry Restore - Dermal tissue reconstructive material, microbe-derived

Device Dossier for My Skin Chemistry Restore - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material,…

Intended purpose

My Skin Chemistry Restore is an injectable device indicated for the temporary correction of the sign of primary soft tissue senile atrophy of the face: restoration of volumes. My Skin Chemistry Restore is intended for adults (over 18 years old) women (not pregnant or breastfeeding) and men with primary senile atrophy soft tissues deficits of the face.

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 superficial dermis. The device packaging includes cannula for convenience.

TGA Public Summary