FDA Clears Aesthetics Biomedical's Vivace Ultra

Posted By Madilyn Moeller, Wednesday, October 26, 2022

Aesthetics Biomedical

The FDA has cleared Aesthetics Biomedical Inc.’s Vivace Ultra, the next generation of personalized aesthetics, for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

An innovative reimagination and technical upgrade of the legacy Vivace Microneedle RF device, the Vivace Ultra combines two unique modalities into one compact device – exclusive uniform radiofrequency microneedling and industry-first, ultrasound imaging and mapping. Vivace Ultra offers the largest variety of frequency options of any RF microneedling device, along with insulated and non-insulated needle sets for smaller precise areas as well as larger areas. In addition, this technology offers four unique delay speeds for optimal time pulses as well as the ability to toggle radiofrequency on or off. An exclusive new feature available solely with Vivace Ultra is a patent pending uniform delivery system designed to evenly distribute heat energy into the dermis, up to 4.0mm (0.1mm step) deep. This feature provides a large leap forward in treatment accuracy.

Using linear array ultrasound technology, Vivace Ultra can visually map the skin across its large 21.5" display screen, allowing an aesthetic provider to develop a personalized treatment in each layer of the skin, delivering robust efficacious clinical results. First-to-market, ultrasound-based imaging and visualization of the epidermis and dermis provide personalized depth measurements to determine the optimal needle depth, eliminating a large portion of guesswork ensuring improved outcomes.

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