Sunny Plus (Sunny)

The Sunny Plus is a low-frequency electrical stimulator that uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. It is a non-invasive device applied through metal and plastic electrodes and is intended for use by medical professionals.

The Sunny Plus operates at a fixed 10 Hz frequency with a shorter pulse width (100–400 µsec) and lower output current compared to the predicate TAMA BEMS device. Both devices use biphasic rectangular waveforms applied transcutaneously, but the Sunny Plus has a single electrode and no burst mode, whereas TAMA BEMS has multiple electrodes and variable frequency (0.045–2560 Hz). The lower current and shorter pulse width of Sunny Plus provide greater patient comfort while maintaining tissue stimulation.

IEC 60601-1:2005 + A2:2020 (general medical electrical equipment safety), IEC 60601-1-2:2014 + A1:2020 (electromagnetic disturbances), IEC 60601-2-10 + A2:2023 (nerve and muscle stimulators), IEC 62304:2006+A1:2015 (software life cycle), EN ISO 14971:2012 (risk management), and IEC TR 60601-4-2 Edition 1.0 2016-05 (electromagnetic immunity guidance).

Both devices use the same principle of operation—transcutaneous electrical nerve stimulation through skin-contact electrodes applied to the face for aesthetic purposes. The essential performance characteristics (output voltage and frequency) are substantially the same. Although differences exist in electrode configuration, pulse width, and current output, these differences do not impact safety or effectiveness; the Sunny Plus's lower stimulation parameters actually enhance patient comfort. The Sunny Plus's fixed 10 Hz frequency falls within the predicate's frequency range, and bench testing confirms accurate output specifications. The devices are biocompatible and meet the same applicable electrical safety standards.