Aime is a robotic platform designed to provide micro-coring for medical aesthetic applications
FDA New York field office which houses Office of Regulatory Affairs. (Credit: CaptJayRuffins from Wikipedia)
Venus Concept, a global medical aesthetic technology leader, today announced it has submitted a 510(k) premarket notification (“510(k)”) to the U.S. Food and Drug Administration (“FDA”), which is intended to obtain a general clinical indication related to the use of its Aime next generation robotic technology for tissue excision and skin resurfacing. Aime is a robotic platform designed to provide micro-coring for medical aesthetic applications.
“We are excited to begin the process of obtaining the first FDA regulatory clearance for our non-surgical robotic technology platform, Aime,” said Domenic Serafino, Chief Executive Officer of Venus Concept. “Aime has the potential to bring true innovation to the medical aesthetics market by changing the way procedures are performed and bringing a new level of consistency and predictability. The submission of this 510(k) brings us one step closer to our goal of commercializing Aime in the U.S., and we look forward to beginning a limited release in the fourth quarter of 2022.”
Source: Company Press Release