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510(k) Data Aggregation

    K Number
    K023221
    Device Name
    CONTACT LASER & DIAGNOSTIC LENSES
    Manufacturer
    VOLK OPTICAL, INC.
    Date Cleared
    2002-10-11

    (14 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Type
    Special
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K051103
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding the "Contact Laser & Diagnostic Lenses" by Volk Optical, Inc. It determines that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. The document is a regulatory approval notice, not a study report.

    Therefore, I cannot provide the requested information from the given input.

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