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

    HO-B-LITE VI UNIT

    K Number: K810668 · Decision Apr 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    27
    Review Days
    42

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    Basic Information

    Device Name
    HO-B-LITE VI UNIT
    K Number
    K810668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    National Biological Corp.
    Date Received
    March 12, 1981
    Decision Date
    April 23, 1981
    Product Code
    KGL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGL Cabinet, Phototherapy (Puva)

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