Zionic Pro Max (Radiofrequency)

The Zionic Pro Max is a non-invasive radiofrequency (RF) heating device with two interchangeable handpieces—one capacitive and one resistive—that deliver RF energy to warm subcutaneous tissue to 40-45°C. It is indicated for topical heating to temporarily relieve pain, muscle spasms, and increase local circulation, and to temporarily reduce the appearance of cellulite.

The device operates at 470 kHz (slightly higher than the predicate's 448 kHz), delivers 200W resistive RF power (same as predicate), but 200W capacitive power (versus the predicate's 500VA). The subject device has 57mm and 90mm electrode sizes with both coated (capacitive) and uncoated (resistive) electrodes, whereas the predicate only had resistive electrodes. Both use non-invasive monopolar radiofrequency technology with skin temperature sensing.

IEC 60601-1 Edition 3.2 (general medical electrical equipment safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 60601-2-2:2017 (high-frequency surgical equipment), IEC 62304:2006+A1:2015 (software life cycle), and EN ISO 14971:2019+A11:2021 (risk management).

Although the capacitive and resistive electrodes use different heat-generation methods, both achieve the same mechanism of action (topical heating). Tissue thermal testing demonstrated that both electrode types maintain 40°C for 10 minutes of treatment, matching predicate performance. The identical indications for use, similar functionality, skin temperature sensing, and equivalent thermal performance despite minor frequency and electrode design differences establish that the device is as safe and effective as the predicate.