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510(k) Data Aggregation

    K Number
    K152452
    Device Name
    Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
    Date Cleared
    2016-05-19

    (265 days)

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

    MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medtek Lighting, LLC's Peacock Tanning, Express Tan Models 1000HT, 2000CT, 2000HT, 3200 are intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years.
    Device Description
    The Express Tan 1000HT device is a skin tanning device, wall mounted or used on an accessory stand with a single lighting panel with 10 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing primary UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing and utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 85.5" high, 5" deep, 22" wide - when door panels are closed. A digital control timer module is used to program exposure times. The Express Tan models1600HT/2000CT/2000HT/3200 are skin tanning devices, wall mounted with 4 lighting panels containing an array of a total of 16, 20, or 32 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing, and that is utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 92" high, 8" deep, 50" wide - when panels are closed.
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    K Number
    K111049
    Device Name
    MOBILE VERSA LIGHT
    Date Cleared
    2012-05-25

    (406 days)

    Product Code
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTEK LIGHTING CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UV Biotek Mobile-Lite model 600 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI) The UV Biotek Versa-Lite model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
    Device Description
    The UV Biotek Mobile-Lite model 600 is a lightweight metal box containing six Philips 15-Watt TL-01 nUVB (narrowband UVB) lamps, configured as a suitcase for portability, designed to be placed either on a table or a stand for easy exposure to feet, lower legs, hands and lower arms. A remote control timer module is used to program exposure times and dosages. The UV Biotek Versa-Lite model 1400 is a phototherapy device, freestanding support with 3 lighting panels containing a total of 14 Philips TL20W/01 (narrowband UVB) lamps. The panels can be used simultaneously or individually, depending on treatment needed. System dimensions: 83" high, 27" deep, and 28" wide - when system panels are in start position.
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    K Number
    K051330
    Device Name
    UVBIOTEK MODELS 3200B AND 4000B
    Date Cleared
    2005-11-18

    (182 days)

    Product Code
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTEK LIGHTING CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.
    Device Description
    Not Found
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