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

    MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE

    K Number: K880930 · Decision May 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
    K Number
    K880930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Copper Lasersonics, Inc.
    Date Received
    March 4, 1988
    Decision Date
    May 31, 1988
    Product Code
    HHR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHR Laser, Surgical, Gynecologic

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