ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)

The ZenTite is an electrosurgical device intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. It also provides topical heating to relieve minor muscle aches, pain, muscle spasm, and temporarily improve local blood circulation. The system consists of a host unit, footswitch, power cord, and interchangeable handpieces with electrodes.

The ZenTite operates at 1MHz frequency with 50W maximum output power in bipolar or monopolar RF modes, identical to the predicate. Key modifications include: addition of parameter memory function for faster setup; adjustable negative-pressure levels (32-84 kPa across three settings, versus fixed 71 kPa ±20% in predicate); optional wireless connectivity for remote updates and device location; and device name/interface updates. All electrode types and treatment durations remain unchanged.

Not stated in this summary.

The subject device and predicate device share the same intended use and fundamental RF technology with identical frequency, power output, and electrode specifications. The modifications—parameter memory, adjustable pressure settings, wireless connectivity, and UI updates—improve usability and workflow without altering intended use or performance. Software verification followed FDA guidance on device software functions, and cybersecurity management addressed security risks. Bench testing confirmed the adjustable pressure function performs as intended. These changes raise no new safety or effectiveness concerns.