Vivace Ultra

Vivace Ultra is a radiofrequency microneedling system sold by Aesthetics Biomedical of Phoenix, Arizona. In FDA's device database, the Vivace Ultra console and parts are tied to 510(k) K221574, which FDA cleared on October 16, 2022 under the name LUDWIG Electrosurgical System. That clearance describes bipolar radiofrequency delivered through microneedle electrodes at up to 50 W, needle extension from 0.5 to 4 mm in 0.1 mm steps, and an ultrasound handpiece for viewing the epidermis and dermis. Its indication is electrocoagulation and hemostasis in dermatologic and general surgical procedures.

FDA's device database breaks the system into parts: an RF applicator that connects the cart to the needle cartridge, an ultrasound transducer held by the operator during scanning, and consoles listed with and without ultrasound. Cartridges come as standard cartridges with 60 needles in a square pattern, offered insulated or non insulated, and as custom cartridges for small, concentrated treatment areas, also insulated or non insulated. All cartridges are listed as single use, sold singly or in packs of ten.

The Ultra is a different machine from the original Vivace, which was made by ShenB and cleared in 2016 and again in 2021. That earlier system uses a 36 electrode cartridge in a 6 by 6 grid with needle depth from 0.5 to 3.5 mm and no imaging. So a console with an ultrasound transducer, or one that takes 60 needle cartridges, is an Ultra. Since the Ultra was offered without ultrasound too, a missing transducer is not proof of an older unit, and the label settles it.

State in your listing whether the ultrasound transducer is included and working, since the two configurations are listed separately. Buyers will also ask about the RF applicator, cable wear, the software version and service history. List unopened cartridges by type and expiry date. Photos of the serial label, the transducer, the applicator and the main screen help a dealer quote accurately.