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510(k) Data Aggregation

    K Number
    K152238
    Device Name
    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
    Manufacturer
    Date Cleared
    2016-03-04

    (207 days)

    Product Code
    Regulation Number
    878.4635
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN CAPSULE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.
    Device Description
    All Sun Capsule models are stand up booths utilizing UV fluorescent lamps arranged on upright walls in a hexagon pattern. Some models also include an optional changing booth. Standard industry construction materials are used including steel trusses, particle board, lighting components, pop rivets, etc. There are no unique materials other than the lamps which use length and diameter combinations that are unique to the tanning industry and not used for general lighting. The number, length, and operating parameters of the lamps of each model differ in order to shorten or lengthen the exposure time desired by the purchaser. Each of the six walls constitutes a lighting fixture containing the lamps, sockets, ballast, wire, connectors and components associated with the lamp sizes required for the particular model. There are no other differences between the models. A digital control timer module is used to program exposure times and the booths are utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c).
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