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

    UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM

    K Number: K872031 · Decision Aug 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    12
    Review Days
    70

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    Basic Information

    Device Name
    UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM
    K Number
    K872031
    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
    May 26, 1987
    Decision Date
    August 4, 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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    K872350 FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE
    K863428 SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
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    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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