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510(k) Data Aggregation
K Number
K151370Device Name
UV Lamps for Indoor Tanning Devices
Manufacturer
LIGHT SOURCES, INC.
Date Cleared
2015-12-17
(210 days)
Product Code
LEJ
Regulation Number
878.4635Why 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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