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

    FIBERLASE 100 MEDICAL LASER SYSTEM

    K Number: K844869 · Decision Jan 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    12
    Review Days
    31

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    Basic Information

    Device Name
    FIBERLASE 100 MEDICAL LASER SYSTEM
    K Number
    K844869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Laser Media
    Date Received
    December 14, 1984
    Decision Date
    January 14, 1985
    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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    Other Clearances by Laser Media

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    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
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