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510(k) Data Aggregation

    K Number
    K991852
    Device Name
    OCUSYSTEM ART ADVANTAGE, MODEL 995
    Manufacturer
    SURGICAL DESIGN CORP.
    Date Cleared
    1999-07-07

    (36 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OCUSYSTEM ART ADVANTAGE, MODEL 995

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

    Phacoemulsification of cataracts in the human eye.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "Ocusystem Art Advantage®" for phacoemulsification of cataracts. It confirms the device's substantial equivalence to a predicate device and permits its marketing.

    However, the document does not describe the acceptance criteria or any study details regarding device performance. It mainly focuses on regulatory aspects and does not include scientific or clinical study data.

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