Device Dossier

Cosmetic phototherapy system, home-use

Device Dossier for Cosmetic phototherapy system, home-use (Cosmetic phototherapy system, home-use, Class IIa, sponsor Skin 2.0). ARTG record, intended…

Intended purpose

The LED Light therapy Facial Mask (Model: MK-03BF) is a home-use wearable LED phototherapy device that can emit LED light in the visible and invisible spectrum, which is intended to use in dermatology for the treatment of mild to moderate inflammatory acne of the face, skin repair, reduction of wrinkles,sun damage, dullness and inflammation, rejuvenate and revitalise the skin, even skin tone and firming skin.

TGA Public Summary