Device Dossier

Cross-linked Sodium Hyaluronate 23 mg/mL – Skin Architect Filler Density - Dermal tissue reconstructive material, microbe-derived

Device Dossier for Cross-linked Sodium Hyaluronate 23 mg/mL – Skin Architect Filler Density - Dermal tissue reconstructive material, microbe-derived…

Intended purpose

A sterile gel for the correction of facial deep skin depressions, face contouring and volume restoration, to be injected into the deep dermis or lip mucosa, as indicated for conditions such as premature skin aging, and to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, and lower face.

Functional description

Pre-filled syringe containing 1 mL of sterile gel with needles, to be injected into the deep dermis or lip mucosa, as indicated for conditions such as premature skin aging, and to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, and lower face. Sodium hyaluronate 23 mg/mL.

TGA Public Summary