BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PASCAL LASER INDIRECT OPHTHALMOSCOPE

    K Number: K123056 · Decision Nov 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    PASCAL LASER INDIRECT OPHTHALMOSCOPE
    K Number
    K123056
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Medical Laser Systems, Inc. (Tmls)
    Date Received
    October 1, 2012
    Decision Date
    November 13, 2012
    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 Topcon Medical Laser Systems, Inc. (Tmls)

    K Number Device Name
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