AGNES Ultra

AGNES Ultra is a radiofrequency electrosurgical device used for electrocoagulation and hemostasis in dermatologic and general surgical procedures. It consists of a main console with LCD screen, RF handpieces (DL, F, and B models), disposable electrodes, a neutral electrode pad, and a foot switch that delivers RF energy at 1MHz through micro-needle electrodes.

The AGNES Ultra operates as a monopolar device at 1MHz with 0–20 power levels (0, 2–32W at 200 ohm), output duration from 50–2000ms, and includes a negative pressure function (off, –25kPa, –35kPa, –45kPa) not present in the predicate RFMagik Lite. Both use oscillating rectangular waveforms, micro-needle electrodes, identical power limits, and EO gas sterilization with 3-year shelf life.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 (electrical safety); ISO 10993 series (biocompatibility); ISO 11135, 11138-1, 11138-2, 10993-7 (sterilization); ISO 11607-1, 11607-2 (packaging); ASTM F1929-15, F88M-21 (packaging integrity); and ex vivo thermal testing per FDA's August 2014 electrosurgical guidance.

The AGNES Ultra and predicate RFMagik Lite share identical regulatory classification (GEI, Class II), indications for electrocoagulation and hemostasis, monopolar operation, 1MHz frequency, equivalent power output (0–32W), matching operating time windows, and identical electrode micro-needle design and sterilization method. The addition of negative pressure function, which is only available on certain handpieces (ROS-25S/D variants), does not raise different safety or effectiveness questions because it is supplementary to the core RF mechanism, and ex vivo thermal tissue testing confirmed the device performs within design specifications across multiple tissue types.