Myolight Microcurrent Handpiece

The MyoLight Microcurrent Handpiece is an aesthetic electrical stimulation device consisting of two interchangeable handpieces (small for face/neck, large for body) that connect to a main control unit with a touchscreen interface. It is indicated for aesthetic use including facial, neck, and body skin stimulation and is sold only to licensed professionals such as aestheticians, med spas, plastic surgeons, and dermatologists.

The device delivers microcurrent via a pulsed biphasic rectangular waveform modulated by trapezoidal envelope at 1-63 Hz frequency with regulated voltage output (30V @ 500Ω, 33V @ 1,000Ω, 35V @ 10,000Ω). It features an LCD touchscreen user interface with microprocessor control, automatic shutoff, and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, and IEC 62366 standards. The contact electrodes are stainless steel 304 and PMMA with conductive silver ink.

IEC 60601-1:2005/A1:2012 (medical electrical equipment general safety), IEC 60601-1-2:2014/EN 60601-1-2:2015 (electromagnetic compatibility), IEC 60601-2-10 Edition 2.1 (nerve and muscle stimulator requirements), ISO 10993 (biocompatibility), ISO 14971 (risk management), and IEC 62366 (usability/human factors).

The device shares the same classification (Class II, NFO product code, 21 CFR 882.5890), identical indications for aesthetic use on face/neck/body, equivalent principle of operation (handpieces with electrodes attached to a control unit with touchscreen and microprocessor), same waveform shape (pulsed biphasic rectangular), and substantially similar electrical characteristics (maximum average power density 0.012 W/cm² at 500Ω matches primary predicate's range). Differences in maximum voltage, current, frequency, and pulse duration are minor parameter variations that do not affect performance or safety given the device's intended aesthetic use and operates within acceptable ranges established by the predicate devices.