Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

The Unicorn+ RF System is a radiofrequency device intended for dermatologic and general surgical procedures for electrocoagulation and hemostasis. It is also used for relief of minor muscle aches, pain, muscle spasm, and temporary improvement of local blood circulation. The system consists of a host unit, trolley, footswitch, power cord, three types of handpieces, and matched electrodes.

The device operates at 1 MHz frequency with a maximum output power of 50W using both bipolar and monopolar RF technology. It includes three treatment modes (MicroRF, Artist, and Pure+B1) with different electrode configurations and penetration depths. Treatment durations range from 10-600ms for MicroRF, 50-5000ms for Artist, and 1-30 minutes for Pure+B1, with electrode tip sizes ranging from 0.5-6.0mm.

Biocompatibility testing per ISO 10993-1, -5, -10, -11, and -23; sterilization validation per ISO 11135:2014 for ethylene oxide; shelf-life validation per ASTM F1980-16; electrical safety and EMC per IEC 60601-1, -1-2, -1-6, and -2-2; ex vivo thermal testing per FDA's August 2014 guidance for electrosurgical devices.

Although the Unicorn+ differs from predicates (POTENZA, AGNES, Capenergy C) in specific output power levels, treatment duration ranges, and electrode dimensions, these variations do not introduce new safety or effectiveness concerns because they achieve similar thermal effects through adjusted treatment parameters. The device uses the same fundamental RF technology at 1 MHz, targets the same indications, operates on the same principles, and thermal damage testing demonstrates comparable safety profiles to the predicates.