510(k) K212322

Cellvizio I.V.E. system with Confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

K212322 is an FDA 510(k) premarket notification submitted by Mauna Kea Technologies for the device "Cellvizio I.V.E. system with Confocal Miniprobes". The FDA issued a decision of Substantially Equivalent on August 18, 2021. 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.