JETT Medical II

The JETT Medical II is a portable medical device for non-ablative treatment of mild to moderate facial wrinkles and rhytids in skin phototypes I-IV. It operates by applying heat to skin tissue through direct current (DC) microcurrents delivered via a handheld pen with interchangeable flat applicators, with a grounding electrode completing the patient circuit.

The JETT Medical II uses DC current at 4.4W maximum power output, compared to the predicate's AC radiofrequency at 4MHz and 120W. The subject device has a touch-screen interface and footswitch activation versus the predicate's buttons/knobs with hand or footswitch options. Both are monopolar, non-ablative systems with similar applicator sizes (3-20mm vs 7.5-20mm), treatment temperature ranges, and multiple adjustable treatment levels.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 (electrical safety and EMC); IEC 62304 (software lifecycle); ISO 10993-1, 10993-5, 10993-10 (biocompatibility); ISO 17665-1 (sterilization validation); ISO 14971 (risk management); IEC 62366-1 (usability engineering).

Although the energy source differs (DC versus RF), bench testing demonstrated that thermal effects on tissue are identical and non-ablative treatment performance is comparable at similar intensity settings. The technological differences in power output, frequency, and user interface do not raise new safety or effectiveness questions because the fundamental principle—heat application to tissue for wrinkle reduction—is identical. Clinical evidence from a prospective multi-center study showed the device met its primary effectiveness endpoint with ≥1 point improvement on the Fitzpatrick wrinkle classification scale in 3-month follow-up, supporting equivalence to the predicate device with the same indications and intended use.