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

    COOLTOUCH VARIA ND:YAG LASER SYSTEM

    K Number: K060966 · Decision Jul 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    115

    Basic Information

    Device Name
    COOLTOUCH VARIA ND:YAG LASER SYSTEM
    K Number
    K060966
    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
    COOLTOUCH, INC.
    Date Received
    April 7, 2006
    Decision Date
    July 31, 2006
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by COOLTOUCH, INC.

    K Number Device Name
    K040921 COOLTOUCH, MODEL NS 160