EndyMed PRO MAX

The EndyMed PRO MAX is a radiofrequency device system consisting of a console and seven interchangeable handpieces for dermatologic procedures. Different handpieces treat muscle pain and spasm, improve blood circulation, reduce wrinkle appearance (at ≤65W), perform skin ablation and resurfacing, or provide electrocoagulation and hemostasis, depending on the handpiece used.

The system operates at bipolar radiofrequency (1 MHz) with maximum output power up to 100W across handpieces, compared to predicates ranging 65–85W. It features an optional thermal camera for temperature monitoring and water cooling, versus fan cooling in the predicate. New handpieces (iFine Max, Mini Shaper Max) are physically smaller with lower power density but maintain therapeutic tissue heating at 39–45°C. Patient-contacting materials remain biocompatible with options for stainless steel or copper-plated electrodes.

IEC 60601-1:2005+A1:2012; IEC 60601-1-2:2014; IEC 60601-2-2:2017; IEC 62304:2006+A1:2015; EN ISO 14971:2012; ISO 11135 (2014); ISO 10993-1:2018; ISO 11607-1:2019-02. Bench testing verified RF energy accuracy; tissue heating testing on human subjects confirmed therapeutic temperature maintenance (39–45°C for ≥10 minutes).

The EndyMed PRO MAX combines previously cleared handpieces (Imagine TC, Contour, Intensif, FSR) into one system with minor modifications (increased wattage, optional thermal camera) and two new smaller handpieces. All operate on identical bipolar RF principles at the same frequency and mode. Tissue heating testing demonstrates the new and modified handpieces achieve and maintain the same therapeutic temperature range as predicates, establishing functional equivalence for pain relief indications. Power density differences on newer handpieces do not introduce additional safety risks and are offset by larger electrode surface areas or lower absolute power to maintain equivalent performance.