Vivace versus Vivace Ultra: same brand name, two devices Vivace and Vivace Ultra are two separate FDA-cleared RF microneedling devices from two separate sponsors. The original Vivace is cleared under K150409 (2016) and K193070 (2021), with ShenB Co. of Seoul, Korea as the sponsor. Vivace Ultra is cleared under K221574 (2022) by Aesthetics Biomed...

What are Vivace cartridges? Vivace cartridges are single-use disposable consumables that mount on a Vivace handpiece. Two distinct cartridge families exist under the Vivace brand name. The original Vivace device by ShenB Co. uses a 36-needle 6×6 array cartridge, cleared under FDA 510(k) K150409 and K193070. The separate Vivace Ultra device by Ae...

What is the Vivace RF microneedling device? Vivace is a bipolar radiofrequency microneedling system manufactured by ShenB Co., Ltd. of Seoul, Korea (formerly Sung Hwan E&B). The device received FDA 510(k) clearance K150409 in January 2016 and was extended under K193070 in April 2021 to add a 2 MHz operating mode alongside the original 1 MHz....