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510(k) Data Aggregation

    K Number
    K151370
    Device Name
    UV Lamps for Indoor Tanning Devices
    Manufacturer
    LIGHT SOURCES, INC.
    Date Cleared
    2015-12-17

    (210 days)

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

    LIGHT SOURCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for the exclusive purpose of cosmetic tanning of the human skin using light between 260-400nm.
    Device Description
    Light Sources UV Lamps for Indoor Tanning devices are ultraviolet lamps that have the same basic technological features and the same intended use. The ultraviolet sunlamps in this submission are classified either as low pressure, or high pressure devices. The main difference for the various models of sunlamps in this submission are: lamp wattage, lamp length, lamp diameter, and spectral emissions. Light Sources UV Lamps for Indoor Tanning devices are ultraviolet sunlamps classified either as low pressure, or high pressure devices emitting light between 260- 400nm. The basic parts are as follows: Bases, Glass Bulb (envelope), Electrodes (Cathodes/Coils), Phosphor Coating, Reflector Coating, Mercury, Inert fill gases.
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