ABM Vivace Receives 2MHz FDA Clearance

Vivace microneedling device receives FDA clearance on 2MHz radiofrequency setting.

Aesthetics Biomedical (ABM), an aesthetic device and topical skin care product development company, recently announced the clearance of their Vivace radiofrequency (RF) microneedling device for use at both 1MHz and 2MHz frequency when treating patients. 

The minimally invasive device is designed to treat different signs of aging, including wrinkles and skin laxity.

The primary setting for Vivace will continue at 1MHz to deliver consistent results, according to a press release. The 1MHz frequency is effective in treating face wrinkles, and fine lines while also improving skin texture and tightening the face and neck. Additionally, the 2MHz setting will now be a secondary option. 

The new 2MHz cleared setting will increase the usability of the device without affecting patient pain or downtime. This will be added to the company’s specialized training program to ensure all practices understand the proper combination of RF level, power settings, and correct needle penetration for desired results. 

“ABM will make available to all practices that utilize the Vivace device with only 1MHz the opportunity to add the 2MHz setting, if desired,” says MaryAnn Guerra, Aesthetics Biomedical’s founder and chief executive officer, Phoenix, Arizona. “Our goal is to provide a best-in-class device with multiple features to address consumer needs.”

Reference:

1. Aesthetics Biomedical receives FDA clearance for Vivace microneedle RF 2mhz treatment setting. Cision PRWeb. June 11, 2021. Accessed June 22, 2021. https://www.prweb.com/releases/aesthetics_biomedical_receives_fda_clearance_for_vivace_microneedle_rf_2mhz_treatment_setting/prweb17994629.htm