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

    PASCAL STREAMLINE 577 (WITH ACCESSORIES)

    K Number: K111108 · Decision Aug 11, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    PASCAL STREAMLINE 577 (WITH ACCESSORIES)
    K Number
    K111108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Medical Laser Systems, Inc.
    Date Received
    April 20, 2011
    Decision Date
    August 11, 2011
    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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