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510(k) Data Aggregation

    K Number
    K023676
    Device Name
    APPLANATION TONOMETER
    Manufacturer
    OPTILASA S.L.
    Date Cleared
    2003-04-24

    (174 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).The device is intended for use in the diagnosis of glaucoma.

    Device Description

    The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding an applanation tonometer. While it confirms the device's substantial equivalence to a predicate device and its intended use, it does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence rather than presenting an exhaustive study report with performance metrics.

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