JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)

The JMOON NouvelleSkin Facial Toning Device is a hand-held, at-home cosmetic device for over-the-counter use. It combines microcurrent electrical stimulation with red (630nm) and near-infrared (855nm) LED light therapy, intended for facial stimulation and treatment of facial wrinkles.

The device delivers three channels of low-level microcurrent pulses (up to 3.8mA at 500Ω, pulsed biphasic rectangular waveform) and multi-level LED irradiance (18–29 mW/cm²). It features software-controlled automatic shut-off, automatic overload trip, and operates on a rechargeable 7.7V/1500mAh lithium-ion battery with a 6-minute treatment cycle.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-2-57, IEC 60601-2-83, IEC 62471, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, and IEC 62133-2 (battery safety).

The device is SE to two predicates: 2 Face/Face Evolution (K171821) for microcurrent function and easy Claire (K213285) for LED function. Although output voltage, current density, pulse parameters, and LED irradiance differ, the applicant demonstrates these differences are minor design improvements that do not raise new safety or effectiveness concerns. Maximum power density (12.11 mW/cm²) complies with FDA guidance limits; net charge (10.50 μC) is well below the 45 μC threshold; and all parameters comply with IEC 60601-2-10 safety standards, consistent with FDA-cleared predicate devices.