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510(k) Data Aggregation

    K Number
    K161764
    Device Name
    SLIT LAMP, Model: YF-100
    Date Cleared
    2017-02-16

    (234 days)

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

    CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 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 slit lamp is an instrument consisting of a high-intensity light source that can be focus to shine a thin sheet of light into the eye. The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structure in detail, enabling diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. The device consists of a base plate, chin rest, fixation light, illumination light, slit project, focusing ring and other accessories that in aid of examination. The patients can rest their chin and forehead on a support to keep the head steady. It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug.
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