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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
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICOR 700 with Auto I/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the MICOR 700 System with Auto I/A 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 from the FDA 510(k) Clearance Letter for the MICOR 700 with Auto I/A does not contain information regarding the acceptance criteria or the study that proves the device meets those criteria. The letter primarily focuses on the regulatory aspects of the clearance, such as the substantial equivalence determination, applicable regulations, and administrative requirements.

    To answer your request, I would need access to a different document, such as the 510(k) summary or the full submission, which typically contains details about performance testing, validation studies, and the established acceptance criteria.

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