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510(k) Data Aggregation

    K Number
    K981989
    Device Name
    THE WAVE DIGITAL PHACO SYSTEM
    Manufacturer
    CIRCUIT TREE
    Date Cleared
    1998-08-25

    (81 days)

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

    THE WAVE DIGITAL PHACO SYSTEM

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

    Phacoemulsification of cataracts in the human eye.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The document is a 510(k) clearance letter from the FDA to Circuit Tree Medical, Inc. for "The Wave Digital Phaco System." It states that the device is substantially equivalent to legally marketed predicate devices for the indication of "Phacoemulsification of cataracts in the human eye."

    This type of FDA letter confirms market clearance but does not typically include detailed study results, performance metrics, or information on how ground truth was established, which are usually found in the 510(k) summary or the full submission.

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