LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)

The LED Light Therapy Mask is a wearable home-use device that emits red, infrared, and blue light to treat full-face wrinkles and mild to moderate inflammatory acne. It consists of a mask unit with LEDs, a controller, and a rechargeable lithium battery. Multiple models (RB-008 through RB-008JB) offer different combinations of light modes to address various skin conditions.

The device uses LEDs at wavelengths of 620nm (red), 460nm (blue), and 850nm (infrared), matching predicate devices. Irradiance levels range from 4–58.7 mW/cm² depending on the light mode and are positioned within the range of comparable predicate and reference devices. The device incorporates Type BF applied-part safety features and is powered by lithium batteries tested to IEC 62133-2.

IEC 60601-1:2020 (general safety and essential performance), IEC 60601-1-2:2021 (electromagnetic disturbance requirements), IEC 60601-1-11:2020 (home healthcare environment requirements), IEC 60601-2-83 (light-based equipment), and IEC 62471 (photobiological safety). Lithium batteries were tested per IEC 62133-2 and FDA guidance documents.

The device is substantially equivalent because its indications for use (wrinkle treatment with red/infrared light; acne treatment with blue light; topical heating with infrared) fall within the scope of multiple legally marketed predicates. Although irradiance and physical dimensions vary slightly from individual predicates, the subject device's specifications remain within the collective range of all predicates and reference devices while meeting the same safety standards (Type BF, IEC 60601-2-83, IEC 62471), demonstrating equivalent safety and effectiveness profiles.