BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICOR 700 with Auto I/A

    K Number: K243395 · Decision Aug 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    281

    Basic Information

    Device Name
    MICOR 700 with Auto I/A
    K Number
    K243395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carl Zeiss Meditec Cataract Technology, Inc.
    Date Received
    October 31, 2024
    Decision Date
    August 8, 2025
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Carl Zeiss Meditec Cataract Technology, Inc.

    K Number Device Name
    K242801 MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
    K214028 MICOR Lens Fragmentation System
    K222236 miCOR System Lens Fragmentation System
    K200207 xPORT S Lens Fragmentation System
    K200584 xPORT 304 (miCOR) System Lens Fragmentation System
    K191024 xPORT Lens Fragmentation System