Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is an FDA 510(k)-cleared medical device (K231075) manufactured by Carl Zeiss Meditec, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2023. Regulation: 8.