RFMagik Lite

The RFMagik Lite is an electrosurgical radiofrequency device consisting of a main unit with two handpieces (RO and AGNES RF) that deliver RF energy through disposable electrodes. It is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, with selectable modes, parameters, and power outputs controlled via a panel interface.

The subject device operates in monopolar mode at 1 MHz frequency with a maximum output power of 32W at 200 ohm impedance, compared to the predicate POTENZA which supports both monopolar and bipolar modes at 1–2 MHz with up to 50W. Both use micro-needle type electrodes with 3-year shelf life and EO gas sterilization. The RFMagik Lite employs two handpiece types and stainless steel needles with 0.4–1.2 mm length and 0.2 mm thickness, whereas POTENZA offers varied electrode tip options with 0.5–2.5 mm length and 0.25–0.35 mm thickness.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993 series (biocompatibility: cytotoxicity, skin sensitization, systemic toxicity, irritation), ISO 11135 (EO sterilization), ISO 11138 (biological indicators), ISO 11607 (packaging and shelf life), ASTM F1929 and F88M (seal testing), and FDA guidance for electrosurgical device thermal testing (March 2020).

Both devices share the same intended indication (dermatologic and general surgical electrocoagulation and hemostasis), the same regulatory classification (Class II, product code GEI), identical RF technology at 1 MHz, monopolar operation, similar electrode type (micro-needle), and comparable electrical safety compliance. Although the predicate supports higher power (50W vs 32W) and bipolar mode, these differences do not introduce new safety or effectiveness questions because the subject device operates within a subset of the predicate's performance envelope. Non-clinical testing—including biocompatibility, electrical safety, EMC, sterility, and ex vivo thermal testing on tissue—demonstrates the RFMagik Lite performs safely and as intended within its specified parameters.