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FDA 510(k)

xPORT 304 (miCOR) System Lens Fragmentation System

K-Number: K200584 · 2020-07-31

ApplicantCarl Zeiss Meditec Cataract Technology, Inc.
Decision Date2020-07-31
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

xPORT 304 (miCOR) System Lens Fragmentation System is a medical device manufactured by Carl Zeiss Meditec Cataract Technology, Inc.. It received FDA 510(k) clearance on 2020-07-31 under approval number K200584. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xPORT 304 (miCOR) System Lens Fragmentation System?

xPORT 304 (miCOR) System Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K200584.

When was xPORT 304 (miCOR) System Lens Fragmentation System approved by the FDA?

xPORT 304 (miCOR) System Lens Fragmentation System received FDA 510(k) clearance on 2020-07-31, under approval number K200584.

What company makes xPORT 304 (miCOR) System Lens Fragmentation System?

xPORT 304 (miCOR) System Lens Fragmentation System is manufactured by Carl Zeiss Meditec Cataract Technology, Inc..

What is the FDA product code for xPORT 304 (miCOR) System Lens Fragmentation System?

The FDA product code for xPORT 304 (miCOR) System Lens Fragmentation System is HQC.

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Other Devices by Carl Zeiss Meditec Cataract Technology, Inc.

K191024xPORT Lens Fragmentation System K200207xPORT S Lens Fragmentation System K214028MICOR Lens Fragmentation System K222236miCOR System Lens Fragmentation System K243395MICOR 700 with Auto I/A K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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