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510(k) Data Aggregation

    K Number
    K093021
    Device Name
    ATLANTIS SLIT LAMP
    Manufacturer
    USOPTHALMIC, LLC
    Date Cleared
    2010-01-28

    (121 days)

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

    USOPTHALMIC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Atlantis 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 segment.
    Device Description
    The Atlantis Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 2 models 2000 and 2000 Plus. These models differ only in the supplied accessories (beam-splitter, camera mount and observation tube). All models have the same operating characteristics and intended use.
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