XERF

XERF is an electrosurgical unit that uses high-frequency radiofrequency energy (2 MHz and 6.78 MHz) delivered through interchangeable electrode tips to treat skin tissue for electrocoagulation and hemostasis. The device is intended for dermatologic and general surgical procedures, with treatment parameters controlled via an LCD touchscreen and activated by foot or finger switch.

XERF is a monopolar RF device generating 2 MHz at up to 300W and 6.78 MHz at up to 400W, with adjustable energy levels (1–120 J at 2 MHz; 1–250 J at 6.78 MHz) and intermittent duty cycle with selectable intervals (off, 200, 500, 800 ms). It offers 12 interchangeable electrode tips ranging from 9×4.5 mm to 27.6×17.6 mm, compared to the predicate Thermage FLX which operates at 6.78 MHz only with fixed-size treatment tips.

IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 60601-2-2:2017+AMD1:2013 (high-frequency surgical equipment), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-1-6:2010+A1:2013+A2:2020 (usability), ISO 10993-1:2018, ISO 10993-10:2021, and ISO 10993-23:2021 (biocompatibility), IEC 62304:2006+A1:2015 (software lifecycle).

XERF specifications are the same as or a subset of the predicate Thermage FLX's specifications, including matching monopolar RF architecture, similar maximum output power (400W at 6.78 MHz), equivalent operational conditions, and identical contact duration and type (intact skin, <24 hours). Ex vivo thermal and histological studies demonstrated that XERF's thermal performance and tissue coagulation profiles are equivalent to Thermage FLX, confirming the device will achieve the same intended clinical effect of tissue coagulation and dermal remodeling.