MiCOR System Lens Fragmentation System

Unit, Phacofragmentation

Carl Zeiss Meditec Cataract Technology Inc.

The following data is part of a premarket notification filed by Carl Zeiss Meditec Cataract Technology Inc. with the FDA for Micor System Lens Fragmentation System.

Pre-market Notification Details

Device IDK222236
510k NumberK222236
Device Name:MiCOR System Lens Fragmentation System
ClassificationUnit, Phacofragmentation
Applicant Carl Zeiss Meditec Cataract Technology Inc. 8748 Technology Way Reno,  NV  89521
ContactGary Mocnik
CorrespondentGary Mocnik
Carl Zeiss Meditec Cataract Technology Inc. 8748 Technology Way Reno,  NV  89521
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-26
Decision Date2022-08-24

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