Finiff System

The Finiff System is a high-frequency electrosurgical unit that uses electrical currents to coagulate tissue. It consists of a console with an RF generator and touchscreen interface, plus two handpieces (VertoRF for microneedling and VitaRF for noninvasive RF delivery) and accessories including power cord, footswitch, cryogen canister, return pad, and coupling fluid. It is intended for use in dermatologic and general surgery procedures requiring electrocoagulation and hemostasis.

The Finiff shares the same indications for use, mode of operation, and overall design as the predicate devices. The VertoRF handpiece delivers energy at 1 MHz and 2 MHz frequencies with 25 needles penetrating up to 4 mm depth, while the VitaRF handpiece delivers noninvasive RF energy at 6.78 MHz. The Finiff operates only in monopolar mode, whereas the predicate devices function in both monopolar and bipolar modes. Slight differences exist in RF duration, but these are not large enough to impact device performance. Both devices have electrode sizes considered substantially equivalent.

Not stated in this summary.

The Finiff System is substantially equivalent because it shares the same indications for use, mode of operation, and overall design as the predicate devices (Potenza and Thermage FLX System). Although the Finiff operates only in monopolar mode while predicates offer both monopolal and bipolar, this functional difference does not create any new safety or efficacy concerns. Bench testing and histology testing demonstrated performance equivalent to the predicate device. No new safety or efficacy risks were identified, establishing substantial equivalence despite the monopolar-only operational limitation.