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

    SUN CAPSULE I & II SUNTANNING BOOTH

    K Number: K871237 · Decision Apr 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    SUN CAPSULE I & II SUNTANNING BOOTH
    K Number
    K871237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sun Capsule, Inc.
    Date Received
    March 27, 1987
    Decision Date
    April 23, 1987
    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 Sun Capsule, Inc.

    K Number Device Name
    K152238 Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5