xPORT Lens Fragmentation System

xPORT Lens Fragmentation System is an FDA 510(k)-cleared medical device (K191024) manufactured by Carl Zeiss Meditec Cataract Technology, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 2019. Regulation: 8.