The FDA has accepted the de novo regulatory submission from Recros Medica for the Nuvellus™ Focal Contouring System. Nuvellus utilizes the company’s proprietary Rotational Fractional Resection (RFR) technology and may provide medical aesthetic physicians a minimally-invasive single treatment option to improve submental (neck and jowl) contouring.
Based on anticipated regulatory timelines, Recros expects to receive FDA clearance in Q4 2019.Following FDA clearance, Recros plans to launch Nuvellus to select medical aesthetic experts, with a broader market rollout to follow.
Nuvellus is a novel alternative to current skin contouring approaches such as traditional surgery and energy-based devices, Recros says. The Nuvellus system will be comprised of an integrated console, reusable surgical handpiece and differentiated consumable attachments for specific contouring applications.
“The entire Recros Medica team is excited about bringing our novel Nuvellus system to aesthetic physicians, and today’s submission represents a critical step in that journey,” says Tom Albright, CEO of Recros Medica. “We are confident that Nuvellus will offer customers significant efficacy and versatility, and look forward to working with the FDA to achieve commercial clearance and introduce Nuvellus for one of the largest unmet needs in aesthetic medicine.”Next Story