Ultrasound lipoplasty device 510(k) clearance may be possible upon downclassification of standard systems.
This article was originally published in The Gray Sheet
Executive Summary
ULTRASOUND ASSISTED LIPOPLASTY DEVICE CLEARANCE VIA 510(k) likely will be allowed for the devices, FDA staffers indicate. Under 510(k) procedures, UAL systems would need clinical data to demonstrate substantial equivalence to standard suction lipoplasty devices.