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

    ULTRATAN TANNING SYSTEM

    K Number: K862372 · Decision Jul 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    4
    Review Days
    15

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    Basic Information

    Device Name
    ULTRATAN TANNING SYSTEM
    K Number
    K862372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Health Systems Intl., Inc.
    Date Received
    June 24, 1986
    Decision Date
    July 9, 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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    Other Clearances by Health Systems Intl., Inc.

    K Number Device Name
    K874232 MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000
    K881492 MTI WOLFF SYSTEM, TANNING BED
    K881353 MTI WOLFF SYSTEM