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510(k) Data Aggregation

    K Number
    K061278
    Device Name
    OPTYSE OPHTHALMOSCOPE
    Manufacturer
    OPHTHALMOS LTD.
    Date Cleared
    2006-05-16

    (8 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMOS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.
    Device Description
    The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.
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