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510(k) Data Aggregation

    K Number
    K973220
    Device Name
    RODENSTOCK LASER SLITLAMP
    Date Cleared
    1997-11-04

    (69 days)

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

    G. RODENSTOCK INSTRUMENTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps are indicated for diagnostic opthalmologic examination of patients with eye disorders. When interfaced with a laser, the device is used for therapeutic treatment of patients where retinal coagulation is indicated.
    Device Description
    The above models of the modified Rodenstock RO 5000 are slitlamp instruments fitted with a laser adapters, and motor activated, metal-coated safety filters. When used with a laser, the laser beam and the beam path of the slit projection are coupled coaxially via beam splitter cubes. This results in the laser focus and the slit image being projected in a common plane. The beam splitter is operated by a micromanipulator, and can be adjusted in any desired direction by pneumatically driven elements.
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