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510(k) Data Aggregation

    K Number
    K243395
    Device Name
    MICOR 700 with Auto I/A
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2025-08-08

    (281 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K242801
    Device Name
    MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2025-06-11

    (267 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.
    Device Description
    MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
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    K Number
    K214028
    Device Name
    MICOR Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2022-09-09

    (261 days)

    Product Code
    HQCMLZ
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the MICOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.
    Device Description
    Not Found
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    K Number
    K222236
    Device Name
    miCOR System Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2022-08-24

    (29 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the miCOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.
    Device Description
    Not Found
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    K Number
    K200207
    Device Name
    xPORT S Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2020-10-15

    (261 days)

    Product Code
    HQCMLZ
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the xPORT S Lens Fragmentation System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation, as well as ancillary functions such as vitreous aspiration and cutting
    Device Description
    Not Found
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    K Number
    K200584
    Device Name
    xPORT 304 (miCOR) System Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc
    Date Cleared
    2020-07-31

    (147 days)

    Product Code
    HQCMLZ
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the xPORT 304 (miCOR) System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.
    Device Description
    Not Found
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    K Number
    K191024
    Device Name
    xPORT Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2019-08-13

    (117 days)

    Product Code
    HQCMLZ
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Meditec Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the xPORT System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.
    Device Description
    Not Found
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