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510(k) Data Aggregation

    K Number
    K080776
    Device Name
    GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
    Manufacturer
    USOPHTHALMIC, LLC
    Date Cleared
    2008-09-09

    (174 days)

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

    USOPHTHALMIC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea 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 eye segments.
    Device Description
    The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination. There are 3 models GR-SL36, GR-SL54, and GR-SL72. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.
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