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510(k) Data Aggregation

    K Number
    K972253
    Device Name
    P3 UNIVERSAL PHACO HANDPIECE
    Manufacturer
    ODYSSEY TECHNOLOGIES, INC.
    Date Cleared
    1997-07-29

    (43 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.

    Device Description

    Odyssey Technologies P3 Universal Handpiece

    AI/ML Overview

    The provided documents do not contain information about acceptance criteria or a study that proves a device meets such criteria. The documents are an FDA 510(k) clearance letter for the "Odyssey Technologies P3 Universal Handpiece," which is used in cataract surgery.

    Specifically, the letter from the FDA to Mr. Glenn A. Dunki-Jacobs of Odyssey Technologies states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory clearance based on equivalence, not necessarily on a performance study with acceptance criteria.

    The information requested in the prompt, such as acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in these documents.

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