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

    ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900

    K Number: K861447 · Decision May 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    1
    Review Days
    26

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    Basic Information

    Device Name
    ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900
    K Number
    K861447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Southern Exposure, Inc.
    Date Received
    April 17, 1986
    Decision Date
    May 13, 1986
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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