LED Light Therapy Mask, Model FM-02

The LED Light Therapy Mask, Model FM-02) is a wearable phototherapy device designed for home use. The system includes a mask, controller, adapter, USB cable, and straps. It delivers light at specific wavelengths to address different skin conditions: red light (620nm) for treatment of full-face wrinkles, blue light (460nm) for mild to moderate inflammatory acne, infrared light (850nm) for topical heating and temporary relief of muscle and joint discomfort, and mixed light (620nm + 850nm + 460nm) for acne management. The device is classified as Class II under 21 CFR 878.4810/890.5500 with product codes OHS, OLP, and ILY, and has been cleared by FDA as substantially equivalent to legally marketed predicate devices

• Red light (620nm): Intended for the treatment of full-face wrinkles.
• Blue light (460nm): Intended for the treatment of mild to moderate inflammatory acne.
• Infrared light (850nm): Provides topical heating for arthritis, muscle spasms, stiffness, relaxation of muscle tissue, and improved local blood circulation.
• Mixed light (620nm + 850nm + 460nm): Intended for the treatment of mild to moderate inflammatory acne.
• Device classification: FDA Class II device under 21 CFR 878.4810/890.5500; system includes mask, controller, adapter, USB cable, and straps.