510(k) K243395

MICOR 700 with Auto I/A by Carl Zeiss Meditec Cataract Technology, Inc. — Product Code HQC

K243395 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec Cataract Technology, Inc. for the device "MICOR 700 with Auto I/A". The FDA issued a decision of Substantially Equivalent on August 8, 2025. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Carl Zeiss Meditec Cataract Technology, Inc. has at least 6 other 510(k) clearances on record.