Device Dossier

Radiesse (+) Lidocaine - Dermal tissue reconstructive material, synthetic mineral, anaesthetic

Device Dossier for Radiesse (+) Lidocaine - Dermal tissue reconstructive material, synthetic mineral, anaesthetic (Dermal tissue reconstructive material,…

Intended purpose

Radiesse (+) Lidocaine Injectable Implant is indicated for plastic / reconstructive procedures, including deep dermal and subdermal soft tissue augmentation of the facial area and is also intended for restoration and correction of fat or volume loss (lipoatrophy) in the facial area and for rejuvenation of the hands.

Functional description

RADIESSE (+) Lidocaine injectable implant is a sterile semi solid implant of suspended synthetic calcium hydroxylapatite in a gel carrier of sterile water for injection, glycerin, sodium carboxymethylcellulose, and 0.3% lidocaine. The gel is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection. Pack contains 1 sterile 0.8mL or 1.5mL syringe and 2 sterile 27G 0.75" needles.

TGA Public Summary