NeurotriS (SX2500); NeurotriS (SX3800)

The NeurotriS SX2500 and SX3800 are microcurrent electrical stimulation devices designed to deliver low electrical current to facial tissues for aesthetic purposes. They use various applicators such as probes, conductive gloves, and pads to deliver the stimulation through one to four independent output channels.

Both devices feature biphasic rectangular waveforms with regulated current and voltage output, software-controlled operation with automatic overload and no-load trip protection, 1–4 output channels delivering identical isolated signals, and maximum output parameters (voltage, current, frequency, and phase duration) substantially matching the predicate devices across multiple load impedances (500Ω, 2kΩ, 10kΩ).

IEC 60601-1-2:2014 (with Amendment 1:2021), IEC 60601-1:2005 with corrections, IEC 60601-1-11:2015+A1, Edition 4.1 EMC (IEC 60601-1-2:2020), and ISO 10993-1:2018 (biocompatibility). Compliance with 21 CFR 989 was also demonstrated.

The SX2500 and SX3800 are substantially equivalent because they share identical intended use (facial tissue stimulation for aesthetic purposes), the same waveform type and output characteristics as predicate devices TAMA (K173093) and Biosonic (K130065), and substantially equivalent applicators (probes, gloves, pads). Although the SX3800 offers up to 4 channels versus the predicate's 1–4 ports, all channels deliver identical isolated signals, and bench testing confirmed output parameters across all simultaneously-active channels match predicate performance. All technological parameters—including voltage, current, frequency, phase duration, net charge, and current density—demonstrated substantial equivalence in the detailed tabular comparison.