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

    PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

    K Number: K123542 · Decision May 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    6
    Review Days
    177

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    Basic Information

    Device Name
    PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
    K Number
    K123542
    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
    November 19, 2012
    Decision Date
    May 15, 2013
    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.

    K Number Device Name
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    K171488 PSLT for PASCAL Streamline
    K111108 PASCAL STREAMLINE 577 (WITH ACCESSORIES)
    K092621 PASCAL STREAMLINE PHOTOCOAGULATOR
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