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510(k) Data Aggregation

    K Number
    K991130
    Device Name
    FLEXPLUG
    Manufacturer
    EAGLE VISION, INC.
    Date Cleared
    1999-04-20

    (18 days)

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

    FLEXPLUG

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

    The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye.

    Device Description

    FlexPlug Punctum Plug

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use Statement" for the FlexPlug Punctum Plug. They do not contain a detailed study report with acceptance criteria and device performance metrics. Therefore, I cannot provide the requested information.

    The FDA clearance letter states that the device is "substantially equivalent" to predicate devices, meaning it has been determined to be as safe and effective as a legally marketed device. This equivalence is based on a comparison of features, materials, and intended use, rather than a prospective clinical trial proving specific performance against hard acceptance criteria.

    To answer your questions, I would need a clinical study report or a detailed summary of the device's performance data, which is not present in these documents.

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