Device Dossier

TKN HA 3 - Dermal tissue reconstructive material, microbe-derived

Device Dossier for TKN HA 3 - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material, microbe-derived, Class III,…

Intended purpose

The product is an injectable sterile, pyrogen-free gel composed of a hyaluronic acid from a non-animal origin in a sodium chloride saline solution. It is intended to hydrate the skin, fill wrinkles in the superficial dermis and improve the skin quality.

Functional description

Non-cross-linked hyaluronic acid product is an injectable sterile,pyrogen-freegel composed of hyaluronic acid from a non-animal origin in a sodium chloridesaline solution. The gel is latex-free,viscoelastic, clear, colorless and biodegradable. TKN HA 3 is provided in sterile,disposable,prefilled syringes;the filling volume is 1.6 mL; the concentration of the hyaluronic acid is 9 mg/mL. TKN HA 3 is intended to hydrate the skin,fill wrinkles in the superficial dermis,and improve skin quality.

TGA Public Summary