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

    LUMENA FH HAIR REMOVAL SYSTEM

    K Number: K140631 · Decision May 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    65

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    Basic Information

    Device Name
    LUMENA FH HAIR REMOVAL SYSTEM
    K Number
    K140631
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shaser, Inc.
    Date Received
    March 12, 2014
    Decision Date
    May 16, 2014
    Product Code
    ONF
    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
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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