BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ORION 3001, LASER PHOTOCOAGULATOR

    K Number: K864063 · Decision Nov 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    3
    Review Days
    24

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    Basic Information

    Device Name
    ORION 3001, LASER PHOTOCOAGULATOR
    K Number
    K864063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    G. Rodenstock Instrumente GmbH
    Date Received
    October 20, 1986
    Decision Date
    November 13, 1986
    Product Code
    HQF
    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
    HQF Laser, Ophthalmic

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    Other Clearances by G. Rodenstock Instrumente GmbH

    K Number Device Name
    K973220 RODENSTOCK LASER SLITLAMP
    K871268 RODENSTOCK SCANNING LASER OPHTHALMOSCOPE