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510(k) Data Aggregation

    K Number
    K041008
    Device Name
    EYE-CEPT REWETTING DROPS
    Manufacturer
    OPTICS LABORATORY, INC.
    Date Cleared
    2005-07-01

    (438 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EYE-CEPT REWETTING DROPS

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

    Use EYE-CEPT® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use EYE-CEPT Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about acceptance criteria, a study that proves a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The document is a US FDA 510(k) clearance letter for a device called "Eye-Cept Rewetting Drops". It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory information and indications for use. It does not contain any performance study data or details about an AI/algorithm-based device.

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