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510(k) Data Aggregation

    K Number
    K033950
    Device Name
    DORC VITRECTOMY LENSES, MODEL 1284 SERIES
    Manufacturer
    DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.)
    Date Cleared
    2004-02-20

    (60 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K012096
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.)

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

    The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.

    Device Description

    D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.

    AI/ML Overview

    This document is a 510(k) summary for the D.O.R.C. Vitrectomy Lens, indicating that it has been found substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory filing, not a scientific study report.

    Therefore, I cannot provide the requested information from the text. The document focuses on regulatory approval based on substantial equivalence, not on performance metrics against predefined acceptance criteria.

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