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

    TRIA FAN SYSTEM

    K Number: K130459 · Decision Oct 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    34
    Applicant Total
    5
    Review Days
    245

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    Basic Information

    Device Name
    TRIA FAN SYSTEM
    K Number
    K130459
    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
    Tria Beauty, Inc.
    Date Received
    February 22, 2013
    Decision Date
    October 25, 2013
    Product Code
    ONG
    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
    ONG Powered Laser Surgical Instrument With MicrobeamFractional Output

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    Other Clearances by Tria Beauty, Inc.

    K Number Device Name
    K160821 Tria Sapphire
    K141868 TRIA FANP
    K120737 TRIA LASER HAIR REMOVAL SYSTEM
    K090312 TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC