Aesthetics Biomedical Gets 510(k) Clearance for Vivace Ultra

Aesthetics Biomedical received 510(k) clearance from the FDA for its Vivace Ultra device, which combines radiofrequency microneedling with ultrasound imaging and mapping for electrocoagulation and hemostasis in dermatologic and general surgery.

The compact device offers a large variety of frequency options, along with insulated and non-insulated needle sets for smaller precise areas as well as larger areas.

The device, which has four delay speeds for optimal time pulses as well as the ability to toggle radiofrequency on or off, can evenly distribute heat energy into the dermis up to four millimeters deep.

The company plans a national rollout of the device in the first quarter of 2023.