Cartessa Virtue RF

Virtue RF is a radiofrequency microneedling system made by ShenB Co. in Seoul and marketed in the United States by Cartessa Aesthetics. FDA first cleared it as VirtueRF under K202415 on January 22, 2021, as a bipolar system with a single SmartRF handpiece running at 1 MHz or 2 MHz and a sterile, disposable 36 needle array. At 1 MHz it is cleared for percutaneous treatment of facial wrinkles in skin types I to V, and at both frequencies for electrocoagulation and hemostasis. A second clearance, K211562 on November 23, 2021, added two more handpieces.

Those additions are DeepRF and ExactRF. DeepRF is bipolar, runs at 0.5, 1 or 2 MHz, takes 12 or 36 needle cartridges, and has a detachable cooling plate with internal water cooling. ExactRF is a monopolar single needle handpiece at 1 MHz that works with a grounding plate. FDA lists maximum power of 35.9 W for SmartRF and up to 220 W for DeepRF at 0.5 MHz. Cartessa describes gold coated needles on SmartRF and DeepRF and a sub pulse delivery mode, and says authorized tips carry RF identification codes that the console confirms on screen.

A VirtueRF is not the same as a Vivace, even though both come from ShenB and the first VirtueRF clearance cited Vivace as a predicate. FDA's device database lists a three handpiece VirtueRF configuration, but between the two 2021 clearances only SmartRF was cleared, so count your handpieces.

Cartridges are single use, and FDA's device database lists SmartRF 36 pin tips in packs of ten. Because the console checks tip codes, a buyer will plan on buying authorized cartridges, so note any sealed boxes you have with their type and expiry date. Also report the DeepRF cooling plate and the ExactRF grounding plate and cable, the software version and service history. Photos of the serial label, each handpiece and the startup screen help a dealer confirm the build.