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

    PSLT for PASCAL Streamline

    K Number: K171488 · Decision Nov 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    6
    Review Days
    189

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    Basic Information

    Device Name
    PSLT for PASCAL Streamline
    K Number
    K171488
    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
    May 22, 2017
    Decision Date
    November 27, 2017
    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
    K180402 PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
    K123542 PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
    K111108 PASCAL STREAMLINE 577 (WITH ACCESSORIES)
    K092621 PASCAL STREAMLINE PHOTOCOAGULATOR
    K043486 PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01