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510(k) Data Aggregation

    K Number
    K152273
    Device Name
    Cosmedico Ultraviolet Lamps of Various Models
    Manufacturer
    Cosmedico Light, Inc
    Date Cleared
    2015-10-30

    (79 days)

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

    Cosmedico Light, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.
    Device Description
    This 510(k) applies to more than one hundred and sixty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercury-rare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof. The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube, 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed. In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hq) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible: that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)
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    K Number
    K152095
    Device Name
    Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
    Manufacturer
    COSMEDICO LIGHT, INC.
    Date Cleared
    2015-10-28

    (92 days)

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

    COSMEDICO LIGHT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.
    Device Description
    This 510(k) applies to more 35 devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as high pressure, mercury-metal halide discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the similar to that of commonly used metal halide lamps used for general lighting purposes. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof. The ultraviolet lamps named herein comprise a tubular quartz envelope, filled with an inert gas (such as argon) and a mixture of mercury and metal halide salts and sealed at both ends.
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    K Number
    K150778
    Device Name
    Various Brands of Ultraviolet Lamps
    Manufacturer
    COSMEDICO LIGHT, INC.
    Date Cleared
    2015-05-29

    (65 days)

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

    COSMEDICO LIGHT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for the exclusive purpose of cosmetic tanning of the human skin.
    Device Description
    This 510(k) applies to more than one hundred and sixty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercuryrare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof. The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube. 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed. In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hg) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible; that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)
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