510(k) K160416

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

K160416 is an FDA 510(k) premarket notification submitted by Mauna Kea Technologies for the device "CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Mauna Kea Technologies has at least 10 other 510(k) clearances on record.