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510(k) Data Aggregation

    K Number
    K180576
    Device Name
    Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
    Manufacturer
    LPI, Inc.
    Date Cleared
    2018-04-19

    (45 days)

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

    LPI, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for the tanning of human skin.
    Device Description
    The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths. - ESB -14, 16, 18, 24, and Oasis 36(booth) - Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth) - Solar Wave 16, 24 - . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth) Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.
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