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

    FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA

    K Number: K872352 · Decision Dec 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    12
    Review Days
    196

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    Basic Information

    Device Name
    FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA
    K Number
    K872352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Laser Media
    Date Received
    June 17, 1987
    Decision Date
    December 30, 1987
    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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    Other Clearances by Laser Media

    K Number Device Name
    K872351 FIBERLASE II ND:YAG LASER FOR PULMONARY USE
    K872350 FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY 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
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