BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION

    K Number: K110129 · Decision Aug 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
    K Number
    K110129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rightmedical Products, LLC
    Date Received
    January 18, 2011
    Decision Date
    August 30, 2011
    Product Code
    HJO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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    Other Clearances by Rightmedical Products, LLC

    K Number Device Name
    K060869 RS-1000 ZOOM SLITLAMP WITH OPTION