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

    COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

    K Number: K003781 · Decision Dec 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    4
    Review Days
    13

    Basic Information

    Device Name
    COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
    K Number
    K003781
    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
    COOLTOUCH CORP.
    Date Received
    December 7, 2000
    Decision Date
    December 20, 2000
    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 CORP.

    K Number Device Name
    K014035 COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
    K010316 COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
    K003715 COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II