LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)

The LED Light Therapy Mask is an over-the-counter device intended for treatment of full-face wrinkles and mild to moderate inflammatory acne. It uses light-emitting diodes in red (630nm), infrared (880nm), blue (415nm), and yellow (590nm) wavelengths to irradiate the face. The device is worn as a mask with LEDs on the inner surface, controlled via a handheld controller, and includes protective eye shields to block light from reaching the eyes.

The device uses LEDs at wavelengths of 630nm (red), 880nm (infrared), 415nm (blue), 590nm (yellow), and 520nm (green). LED power ranges from 3-40 mW/cm² depending on the mode. Treatment times vary from 3 to 10 minutes depending on the model and mode selected. The device is powered by lithium-ion polymer batteries (600-2850mAh) or AC adapters. It incorporates materials including silicone, ABS plastic, polycarbonate, and metal components designed for skin contact lasting less than 24 hours.

IEC 60601-1 (medical electrical equipment basic safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-57 (non-laser light source equipment), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation testing).

The subject device and predicate devices (K242593, K241857, K242796, K230351, K230042) share identical intended uses (treatment of wrinkles and acne), the same regulatory classification (Class II), and substantially similar technological characteristics including identical treatment wavelengths (630nm, 880nm, 415nm), comparable LED power densities, and similar treatment protocols. Minor differences in power supply, LED power specifications, treatment time, and dimensions are deemed insignificant because the device passed the same safety and performance standards (IEC 60601 series, IEC 62471, ISO 10993 biocompatibility tests) as the predicates, demonstrating equivalent safety and effectiveness.