SofWave System

The SofWave System is a non-invasive aesthetic treatment device combining ultrasound and electrical muscle stimulation. It is indicated to improve facial lines and wrinkles, lift the eyebrow and neck tissue, treat cellulite and acne scars, improve skin laxity on the upper arms, and strengthen abdominal and limb muscles through the Pure Impact module for muscle training in healthy subjects aged 22 and older.

The SofWave module uses high-intensity non-focused ultrasound at 10-12 MHz delivered through an array of transducers with active cooling, producing 3-5 Joules per piezoelectric transducer. The Pure Impact module is a wireless electrical muscle stimulator generating symmetrical biphasic square-wave pulses at regulated current (up to 102 mA at 500 Ω, 1-150 Hz frequency, 50-500 µs pulse width) across up to 6 output channels. Minor hardware modifications were made to the SofWave ultrasound module without changing treatment parameters or energy specifications.

Electrical safety and electromagnetic compatibility per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62; risk management per ISO 14971; software verification and validation performed; functional bench testing confirmed performance.

The subject device's SofWave module is substantially equivalent because it maintains identical energy delivery (3-5 J/PZT), treatment areas (15, 35, 70 mm²), and operating principles as predicate K241685, with only minor hardware changes that do not alter treatment parameters. The Pure Impact module is substantially equivalent because its electrical stimulation waveforms, output parameters, and muscle training indication match the predicate devices (K241685 and K221200), with similar safety features and performance characteristics that raise no new questions of safety or effectiveness.