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

    OPELASER PRO II AND THE OPELASER LITE II

    K Number: K120932 · Decision Dec 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    9
    Review Days
    254

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    Basic Information

    Device Name
    OPELASER PRO II AND THE OPELASER LITE II
    K Number
    K120932
    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
    The Yoshida Dental Mfg. Co., Ltd.
    Date Received
    March 28, 2012
    Decision Date
    December 7, 2012
    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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