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510(k) Data Aggregation

    K Number
    K202670
    Device Name
    Nam illumination probe with chopper
    Manufacturer
    Oculight Ltd.
    Date Cleared
    2021-08-20

    (340 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculight Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.
    Device Description
    This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.
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