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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
    HQC,MLZ
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICOR Lens Fragmentation System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the MICOR Lens Fragmentation System and does not contain any information about acceptance criteria or specific study details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the given document.

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