DESCRIPTION

It is a sterile pyrogen-free physiological gel of crosslinked hyaluronic acid, of non-animal

origin. It is a colorless, odorless and highly viscous aqueous gel. It is supplied in a glass

syringe with a luer-lock fitting. The contents of the syringe. Have been sterilized using moist heat. The product is for single use only. Disposable sterile Needles are provided with each     syringe. Information about the sterilization method and size of the needle is printed on its

packaging. The number of units per package and the volume contained in each syringe is as started on the outer package.

PRINCIPLES OF OPERATION

Device is a cross-linked sodium hyaluronate gel that acts by adding volume to the tissue. The hyaluronic acid molecules’ hydrophilic nature combined with its three-dimensional structure allows the molecules to bind water many times its own weight. The addition of water helps to maintain the overall volume of the product resulting in a longer duration. Device is naturally integrated into the tissue and will in time undergo isovolemic degradation. The isovolemic pattern of degradation increases the water binding capacity of the gel, thus allowing Device to maintain the overall volume during the degradation process