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

The LED Light Therapy Mask (Model: LED Face Mask Pro FAC08NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Blue light(415 nm): Intended for treatment of mild to moderate inflammatory acne. 5. Blue and Red (415 nm and 630 nm): Intended for treatment of mild to moderate inflammatory acne. 6. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The LED Light Therapy Mask (Model: LED Chest Mask Pro FAC09NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.