Device Dossier

Aliaxin SR Shape & Restore - Dermal tissue reconstructive material, microbe-derived

Device Dossier for Aliaxin SR Shape & Restore - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material,…

Intended purpose

Aliaxin® SR Shape & Restore is indicated for the treatment of imperfections in the following areas of the face: • nasolabial folds • wrinkles around the mouth • facial and acne scars • glabellar wrinkles • wrinkles on the forehead • areas of the face which require enrichment of the facial tissue (cheeks, chin, cheek-bones, lips) with temporary volumetric increase through growth of the soft tissues

Functional description

Aliaxin® SR Shape & Restore is a reabsorbable medical device (physiological, apyrogenous sterile gel) to be used as a filler for the correction of medium and deep facial cutaneous sagging and to increase the volume and contours of the lips. The principle component is cross-linked Hyaluronic Acid of non-animal origin, produced by bacterial fermentation. The pack contains: 2 prefilled syringes of 1ml 2 Backstop 2 Needles TSK 30G – 13mm 2 Needles TSK 27G – 19mm

TGA Public Summary