Inbella RF System

The Inbella RF System is a radiofrequency-based electrosurgical device that generates RF energy with automatic temperature and impedance feedback to control tissue heating. It is indicated for dermatological and general surgical procedures requiring soft tissue coagulation, contraction, or hemostasis. The system consists of a power supply, RF generator, controller with touch screen interface, handpiece connected via cable, and foot switch activation.

The Inbella RF System is identical in all technological aspects to the InMode RF System predicate device (K240780), including the AC/DC power supply unit, RF generator, controller, touch screen interface, cable-connected RF handpiece, and disposable single-use plastic handles with active internal electrodes. Some handpieces include both internal (active) and external (return) electrodes. The only difference between the devices is the manufacturer and 510(k) holder.

The device complies with ANSI AAMI ES 60601-1:2005/(R)2012 and amendments (medical electrical equipment general safety requirements), IEC 60601-1-2 Edition 4.0 2014-02 (electromagnetic disturbance requirements), and IEC 60601-2-2 Edition 6.0 2017-03 (high frequency surgical equipment safety and performance requirements).

The Inbella RF System is substantially equivalent to the InMode RF System predicate because the devices are identical in design, function, indications for use, and technological characteristics. Since the predicate was already cleared and demonstrated safety and effectiveness, and Inbella's device is merely a rebranded version with the same specifications and intended use, no new bench, animal, or clinical data were needed to support substantial equivalence.