LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

The LED Facial Mask is an over-the-counter, wearable home-use device that emits red light (633nm) and near-infrared light (830nm) to treat full-face wrinkles. Multiple models (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) are cleared with similar specifications but varying battery capacities and pulse frequencies.

The device uses silicone housing with integrated LEDs and a microprocessor controller. Red light irradiance ranges from 15-35 mW/cm² and near-infrared from 15 mW/cm² depending on model. Models differ in pulse frequency (2kHz or 22kHz) and battery capacity (1200-5200mAh lithium-ion). All emit the same wavelengths and comply with IEC 60601 series standards for electrical safety and electromagnetic compatibility.

IEC 60601-1 (electrical safety), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser light source equipment), IEC 60601-1-2 (electromagnetic compatibility), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), and ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation).

The subject device is substantially equivalent to predicates K201107 and K241933 because it shares identical intended use (wrinkle treatment), same anatomical site (full face), same energy type (LED), same wavelengths (633nm red, 830nm NIR), same regulatory class (Class II), same product code (OHS), and meets the same safety standards. Differences in irradiance and housing materials do not raise new safety or effectiveness questions and fall within ranges of previously cleared devices.