Device Dossier

Sunekos Performa - Dermal tissue reconstructive material, microbe-derived

Device Dossier for Sunekos Performa - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material, microbe-derived,…

Intended purpose

Sunekos Performa is intended to integrate the extracellular matrix by exerting a filling effect on anatomically depressed areas of the skin, such as wrinkles and folds, promoting the normalization of imperfections and promote the restoration of hydration and the physiological elasticity of the skin tissue. The device is indicated for use in the correction of mild to moderate imperfections and depressions of the skin of the face and neck.

Functional description

Sunekos Performa is an injectable and resorbable solution, sterilized by filtration, based on non-cross-linked (linear) hyaluronic acid and a specific cluster of six amino acids. Hyaluronic acid is a critical component of the extracellular matrix of most tissues, including the skin.

TGA Public Summary