MICOR 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 Lens Fragmentation System.

Pre-market Notification Details

Device IDK214028
510k NumberK214028
Device Name:MICOR 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-22
Decision Date2022-09-09

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.