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

    FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE

    K Number: K872350 · Decision Aug 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    12
    Review Days
    54

    Basic Information

    Device Name
    FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE
    K Number
    K872350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    LASER MEDIA
    Date Received
    June 17, 1987
    Decision Date
    August 10, 1987
    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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    Other Clearances by LASER MEDIA

    K Number Device Name
    K872352 FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA
    K872351 FIBERLASE II ND:YAG LASER FOR PULMONARY USE
    K872031 UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM
    K863428 SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
    K863583 CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER
    K862444 FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
    K860063 ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM
    K855197 FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM
    K852798 FIBERLASE 100 MEDICAL LASER SYSTEM
    K850509 ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM
    Search all 12 clearances from LASER MEDIA →