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

    SUNSHOWER MODEL HU-01-12L

    K Number: K850493 · Decision Feb 28, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    20

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    Basic Information

    Device Name
    SUNSHOWER MODEL HU-01-12L
    K Number
    K850493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sunthetic Engineering, Inc.
    Date Received
    February 8, 1985
    Decision Date
    February 28, 1985
    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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    Other Clearances by Sunthetic Engineering, Inc.

    K Number Device Name
    K862263 PERSUNAL TAN, MODEL NO. HU-0208L