LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

The LED Light Therapy Mask (models M19, M19-1, M19-2, M19-3, M19-5, M19-6) is an over-the-counter, wearable home-use device that emits LED light at multiple wavelengths (red 660nm, infrared 850nm, yellow 590nm, and blue 460nm) to treat full-face wrinkles and mild to moderate inflammatory acne. The device consists of a mask unit, controller, and USB charging cable powered by a rechargeable lithium battery.

The device uses light-emitting diodes (LEDs) with four spectrum wavelengths and operates in three modes combining different wavelengths (red+infrared, red+blue+infrared, yellow+infrared). It has adjustable intensity and treatment time (5/10/20 minutes) controlled via a handheld controller. The irradiance ranges from 5–33 mW/cm² depending on mode, with a rechargeable 3.7V 2000mAh lithium battery.

Biocompatibility testing per ISO 10993-5, 10993-10, and 10993-23; electrical safety per IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-83; battery safety per IEC 62133-2; and eye safety per IEC 62471. Software was validated to Basic Documentation Level of concern.

The subject device has the same intended use and indications as the predicate devices (treatment of wrinkles and acne via LED phototherapy). It demonstrates similar technological characteristics, light sources, wavelengths, irradiance levels, and treatment parameters, with only minor dimensional differences that do not raise safety or efficacy concerns. Performance data from biocompatibility, electrical safety, and software testing support equivalence to legally marketed predicate devices.