Microcurrent Facial Device (CEC101, EE0101, EEI101)

The Microcurrent Facial Device (models CEC101, EE0101, EEI101) is a portable, handheld, battery-powered stimulator intended for over-the-counter aesthetic use. CEC101 and EE0101 are designed for facial stimulation, while EEI101 extends treatment to the face, neck, and body. The device delivers microcurrent electrical stimulation via electrodes and is controlled by firmware with multiple output modes and intensity levels.

The subject device uses a single output channel with voltage-controlled biphasic square-wave pulses, delivering 40–97.8 Hz frequencies at adjustable intensity levels (2–10 levels depending on model). Key electrical parameters fall within or near predicate ranges: maximum output voltages 3.54–34 V across different impedances; maximum currents 3.13–7.54 mA; pulse widths 145–174 μs. The device incorporates automatic shut-off, user override control, on/off and low-battery indicators, software/firmware control, and is powered by a 3.7V rechargeable lithium-ion battery. Materials include ABS and stainless steel; the device is non-sterile and reusable.

Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation). Electrical safety and EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2 (lithium battery safety). Software documentation per Basic Documentation requirements with verification and validation testing.

The device is substantially equivalent because it shares the same regulatory classification (Class II, 21 CFR 882.5890), product code (NFO), intended use (over-the-counter aesthetic skin stimulation), and fundamental design (handheld, battery-powered microcurrent stimulator with software control). Although minor differences exist in output modes, intensity levels, dimensions, and specific electrical parameters, the submitter argues these are insignificant because: (1) the maximum and minimum electrical outputs remain within predicate ranges, (2) all electrical safety, EMC, and biocompatibility testing passed applicable IEC and ISO standards, and (3) the waveform parameters are similar to predicate device 1 and meet IEC 60601-2-10 requirements.