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510(k) Data Aggregation

    K Number
    K133019
    Device Name
    FIBERION OPHTHALMIC ENDOLASER PROBE
    Date Cleared
    2015-02-20

    (512 days)

    Product Code
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Fiberion Ophthalmic Endolaser Probes are in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached
    Device Description
    Fiberion endolaser probes are designed to be connected to ophthalmic laser photocoagulators and to transmit laser energy inside the patient's eye. One end of the probe contains a connector for attachment to the laser unit, the other, a tip section to be introduced inside the eye. Device components are an input connector, a glass fiber optic protected by a buffer coating, a protective tubing, an aluminum handle with a medical grade stainless steel needle. The illuminating endolaser probe has an additional illumination fiber optic.
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