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

    MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS

    K Number: K880170 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    54
    Review Days
    69

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    Basic Information

    Device Name
    MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
    K Number
    K880170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    January 15, 1988
    Decision Date
    March 24, 1988
    Product Code
    LLO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLO Laser, Neodymium:Yag, Pulmonary Surgery

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    K880428 ILLUMINA 25 CO2 LASER SYSTEM
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    K880171 MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
    K880173 MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
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