Aesthetics Biomedical's Vivace Ultra Wins FDA Clearance

Aesthetics Biomedicals Vivace Ultra Wins FDA Clearance image

The full national rollout for Vivace Ultra is planned for Q1 2023.

The FDA has given the nod to Aesthetics Biomedical Inc.’s Vivace Ultra 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, the next generation and of personalized aesthetics, 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.

Medical aesthetic providers will have the ability to store treatment data on a variety of areas and receive recommendations for optimal treatment. Patient experience and colorblind versatility is core to Aesthetics Biomedical’s legacy Vivace Experience branding and treatment, so Vivace Ultra is virtually pain-free for the patient, and effective for light to dark skin types. In addition to visualization, the ultrasound software offers HIPAA compliant cloud connectivity harnessing the ability to collect data about the patient’s various treatment areas beyond the surface for an optimized treatment plan.

A recent radiofrequency clinical study found that 95% of patients noticed an improvement in skin texture after a series of treatments between 2-6 sessions. Ninety four percent of these patients said they would recommend radiofrequency microneedling to a friend. On the RealSelf platform, the legacy Vivace Microneedle RF treatment has become the most requested microneedling treatment. Building upon an already best-in-class device, Vivace Ultra has been developed alongside and in collaboration with key opinion leaders (KOLs). The new device’s technology and user-friendliness is based on years of clinical and user feedback from top plastic surgeons, dermatologists and medical aesthetic practitioners.

“The expeditious clearance of Vivace Ultra, allows us to provide physicians, aesthetic practitioners and patients the unmatched precision and unique visualization in the most advanced and versatile radiofrequency (RF) microneedling technology, for the entire body, in the market,'' said MaryAnn Guerra, CEO. “Several years in development, we are incredibly proud to usher in the new era of energy-based technology, first ultrasound imaging and data support optimization representing a large leap forward in treatment accuracy and personalization. We are thrilled to follow Aesthetics Biomedical’s development of the first personalized, topical skincare product SoME® Skincare, with the first generation of personalized energy-based devices!”

A recent clinical study by research dermatologist, Zoe Diana Draelos, MD, was conducted to verify the ultrasound calibration accuracy of Vivace Ultra to visualize all layers of skin. Of the 30 healthy [male and female] individuals empaneled, 18 years or older, five subjects were each Fitzpatrick Skin Type I-VI. Examining 31 anatomical parts, three measurements were taken at each site at baseline and at 6 weeks. Results concluding highly reproducible, and very reliable images across a diverse human subject base will be published in a peer reviewed publication this later this year.

The Vivace Ultra, developed and manufactured by Aesthetics Biomedical Inc., also leads the market as the first and only RF microneedling device manufactured in the US. FDA clearance of the new device by Aesthetics Biomedical creates a new category that redefines what is possible in personalized medical aesthetics. Additionally, the company says it lends credibility to the Aesthetics Biomedical Innovation Center, expanding its position within the medical aesthetic market as well as further establishing the company as an innovation leader laying groundwork for future developments. The full national rollout for Vivace Ultra is planned for Q1 2023.

Learn more on this new device in the upcoming November/December 2022 issue of Modern Aesthetics® magazine with an exclusive interview with one of Vivace Ultra’s earliest adopters New York City dermatologist Marie V. Hayag, MD.

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