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

    PLASMALUXLS

    K Number: K100628 · Decision Nov 24, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    15
    Review Days
    264

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    Basic Information

    Device Name
    PLASMALUXLS
    K Number
    K100628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Daavlin Distributing Co.
    Date Received
    March 5, 2010
    Decision Date
    November 24, 2010
    Product Code
    ONE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONE Powered Light Based Non-Laser Surgical Instrument

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