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510(k) Data Aggregation

    K Number
    K023939
    Device Name
    VELOCITY ADVANTAGE
    Manufacturer
    VISION CARE DEVICES, INC.
    Date Cleared
    2003-04-17

    (142 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VELOCITY ADVANTAGE

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

    The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Velocity Advantage" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

    The letter primarily confirms that the device is substantially equivalent to a predicate device and can therefore be marketed. It lists the device name, a brief indication for use, and regulatory information.

    Therefore, I cannot extract the requested information from this document.

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