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

    MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL

    K Number: K880171 · Decision Apr 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    54
    Review Days
    87

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    Basic Information

    Device Name
    MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
    K Number
    K880171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    January 15, 1988
    Decision Date
    April 11, 1988
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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    K880428 ILLUMINA 25 CO2 LASER SYSTEM
    K880808 ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU
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    K880170 MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
    K880173 MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
    K880172 MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
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