LED Light Therapy Mask (2311, 2344, 2457, 2458)

The LED Light Therapy Mask is an over-the-counter device that uses light-emitting diodes in red (630nm), blue (460nm), amber (605nm), and infrared (850nm) wavelengths to treat full-face wrinkles and mild to moderate inflammatory acne. The mask contains LEDs on its inner surface, covers the face, and includes an eye-shield to block light from reaching the eyes during treatment.

The device uses LED light sources at specified wavelengths similar to predicate devices, with adjustable treatment times (10–30 minutes) and selectable modes. LED intensity varies by model and mode (ranging from 3.5 to 31 mW/cm² for red light), powered by lithium polymer or lithium-ion batteries with external AC adapters. All models incorporate a protective eye-shield and controller for mode selection and timing.

Biocompatibility testing per ISO 10993-5, ISO 10993-10, and ISO 10993-23; electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83; battery safety per IEC 62133-2; and photobiological eye safety per IEC 62471. Software validation was performed consistent with basic documentation requirements.

The LED Light Therapy Mask is substantially equivalent because it shares the same intended use (wrinkle and acne treatment via LED phototherapy), same regulatory classification (Class II), same product codes (OHS, OLP), and comparable technological characteristics (LED wavelengths, intensity ranges, treatment durations, and safety features) with three legally marketed predicate devices. Performance testing demonstrates similar safety and effectiveness profiles, including equivalent biocompatibility, electrical safety, and eye safety margins, with no novel design features that would raise new safety or effectiveness questions.