Ignite RF System

The Ignite RF System is a computerized radiofrequency (RF) energy system indicated for dermatological and general surgical procedures requiring soft tissue coagulation, contraction, or hemostasis. It consists of a console with power supply, RF generator, controller, and touch-screen display, connected to various RF handpieces (monopolar, bipolar, and Morpheus8 applicators) that deliver RF energy to tissue.

The Ignite RF System features a similar design and components to predicate devices, including an AC/DC power supply, RF generator, controller, and handpieces with cables and connectors. The main modification is the addition of new Burst and Scale Modes for Morpheus8 handpieces that deliver multiple pulses at different depths (2 mm apart) per needle activation. No new handpieces or patient contact materials were introduced; software and cybersecurity documentation were validated per FDA guidance.

Not stated in this summary.

The Ignite RF System is substantially equivalent because it has identical indications for use, similar design and components, and equivalent safety features as the predicate InMode RF systems (K240780 and K231790). Comparative ex vivo thermal safety testing demonstrated that the new Burst Mode produces independent coagulation zones without overlap, with no histological difference from previously cleared treatment modes. A multi-site clinical study with 30 subjects per treatment location showed comparable adverse event incidence, duration, and severity between Burst and Cycle modes, with equivalent pain tolerability scores.