Aesthetics Biomedical’s Vivace Ultra microneedling RF device was cleared by the FDA for use in dermatological and surgical procedures.

Aesthetics Biomedical’s Vivace Ultra has cleared the United States Food and Drug Administration (FDA), intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

A 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 ultrasound imaging and mapping.

Vivace Ultra offers a large variety of frequency options along with insulated and non-insulated needle sets for smaller precise areas as well as larger areas.

In addition, the technology offers four unique delay speeds for optimal time pulses as well as the ability to toggle radiofrequency on or off. It features a uniform delivery system designed to evenly distribute heat energy into the dermis, up to 4.0mm (0.1mm step) deep to improve treatment accuracy.

Using linear array ultrasound technology, Vivace Ultra can visually map the skin across its 21.5-inch display screen, allowing an aesthetic provider to develop a personalized treatment in each layer of the skin, delivering robust efficacious clinical results.

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 and 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. 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.

“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, chief executive officer of Aesthetics Biomedical. “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.”

Photo courtesy of Aesthetics Biomedical