CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)

The CurrentBody Skin LED Light Therapy Mask Series 2 (Model MK-90H) is a wearable over-the-counter device intended for treating full-face wrinkles. It is a flexible silicone mask containing red (633nm) and near-infrared (830nm) light-emitting diodes that the user wears on their face for 10-minute treatment sessions.

The device emits red light at 633nm and infrared light at 830nm with a total intensity of 30 mW/cm² and a dose of 18 J/cm² per treatment. It contains 110 LEDs at each wavelength, powered by a rechargeable 3.7V lithium-ion polymer battery (2600mAh, 9.62Wh). The subject device wavelengths (633nm, 830nm) are slightly narrower than the predicate's tolerance range (630±5nm, 830nm) but fall within acceptable limits; the LED count differs (110 vs. 66 per wavelength) but maintains identical total intensity and dose.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471 (electrical safety and photobiological safety); IEC 62133-2 (battery safety); ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); FDA Guidance for Software Content in Medical Devices (software verification and validation).

The subject device is substantially equivalent because it shares identical intended use (treatment of full-face wrinkles), same product classification (Class II, OHS product code, 21 CFR 878.4810), identical treatment parameters (10-minute sessions, 5× weekly for 6 weeks, 18 J/cm² dose, 30 mW/cm² intensity), and compliant design. Minor differences—wavelength precision (633nm vs. 630±5nm) and LED distribution (110 vs. 66 per wavelength)—do not raise new safety or effectiveness concerns because they remain within established safety standards and produce equivalent optical output. Biocompatibility materials are unchanged from previously cleared devices, and electrical/photobiological safety testing confirms compliance with the same standards as the predicate.