Device Dossier

Blue/red/infrared phototherapy lamp

Device Dossier for Blue/red/infrared phototherapy lamp (Blue/red/infrared phototherapy lamp, Class IIa, sponsor Kingsmead). ARTG record, intended…

Intended purpose

LED light therapy mask (FM-01, FM-02, FM-03) Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne.

TGA Public Summary