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

    LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35

    K Number: K860822 · Decision Apr 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    54
    Review Days
    44

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    Basic Information

    Device Name
    LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
    K Number
    K860822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    March 4, 1986
    Decision Date
    April 17, 1986
    Product Code
    FAJ
    Advisory Committee
    Gastroenterology, Urology
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    K880428 ILLUMINA 25 CO2 LASER SYSTEM
    K880808 ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU
    K880809 ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
    K880171 MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
    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.
    Search all 54 clearances from Cooper Lasersonics, Inc. →