Therapy Areas: Devices
Recros Medica announces US FDA De Novo submission for Nuvellus Focal Contouring System
8 May 2019 -

Dermatology company Recros Medica Inc said on Tuesday that it has successfully filed its de novo regulatory pathway with the US Food and Drug Administration (FDA) to expedite the regulatory review the Nuvellus Focal Contouring System for the aesthetic market.

The company added that Nuvellus is a novel alternative to current skin contouring approaches including traditional surgery and energy-based devices. The Nuvellus system will be comprised of an integrated console, reusable surgical handpiece and differentiated consumable attachments for specific contouring applications.

According to the company, Nuvellus utilises its proprietary Rotational Fractional Resection (RFR) technology, which may provide medical aesthetic physicians a minimally-invasive single treatment option to improve submental (neck and jowl) contouring.

Following the expected US FDA clearance in Q4 2019, the company intends to introduce the Nuvellus to select medical aesthetic experts, followed by a broader market rollout.