BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    LIGHTLAS MODEL 532

    K Number: K091534 · Decision Sep 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    62
    Same Product Code
    176
    Applicant Total
    9
    Review Days
    115

    Basic Information

    Device Name
    LIGHTLAS MODEL 532
    K Number
    K091534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LIGHTMED CORP.
    Date Received
    May 26, 2009
    Decision Date
    September 18, 2009
    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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