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510(k) Data Aggregation

    K Number
    K153545
    Device Name
    Portable Slit Lamp
    Date Cleared
    2016-06-22

    (194 days)

    Product Code
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BL-5000 portable slit lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye
    Device Description
    The BL-5000 portable slit lamp is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The BL-5000 portable slit lamp is composed of the following components: microscope unit, illumination unit, base unit and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes.
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