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510(k) Data Aggregation

    K Number
    K980085
    Device Name
    PHACO COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1998-02-24

    (46 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHACO COMMANDER

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

    Emulsification and aspiration of cataract

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the PHACO COMMANDER system, dated February 24, 1998. It confirms the device is substantially equivalent to legally marketed predicate devices for the indication of "Emulsification and aspiration of cataract."

    Unfortunately, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a scientific study report.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as that information is not present in the provided text.

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