510(k) K231075

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) by Carl Zeiss Meditec, Inc. — Product Code IZI

K231075 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)". The FDA issued a decision of Substantially Equivalent on June 20, 2023. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.