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510(k) Data Aggregation

    K Number
    K090831
    Device Name
    TANTHERA-T35
    Manufacturer
    Date Cleared
    2009-05-29

    (64 days)

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

    TANTHERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to provide ultraviolet light to tan the skin.
    Device Description
    The TanThera-T35 ("T35") is a tanning chamber employing UVA1 (340 nm - 400 nm) light-emitting diode ("LED") technology as the ultraviolet light source in order to provide a tanning response to human skin. It is designed in a clam-shell format with an upper ("canopy") and lower ("bench") radiant surface in order to provide a two-sided tan with a person in supine position on an acrylic platform. The principle parts of the T35 include multiple T35 LED Modules, forty-four (44) copper tube heat sink with a linear array of thirty-eight (38) T35 LED Modules each, a T-Max ® Timing System, a temperature control system, and a chilled-water liquid cooling system. The copper tube arrays with temperature equalizing internal counter-current flow dams, are arranged with twenty-six (26) tube arrays on the canopy and eighteen (18) tube arrays on the bench. The tube arrays are mounted behind a diffuse reflector that has cutouts for each of the T35 LED Modules. There is an acrylic shield between the tanner and the arrays to prevent tampering and contact with T35 LED Modules as well as to provide a minimum distance from the emitters to the tanner. The liquid cooling system has temperature and flow controls that sense and control water flow to maintain the LED modules at an operating temperature range. The bed is designed to terminate operation if the operating parameters of the T35 LED Modules are not met. Should the T35 LED Module temperature increase due to low coolant flow or high coolant inlet temperatures then the session terminates to prevent overheating and possible early burnout of the LED modules. A failure of the cooling system decreases LED lifetime but does not pose a significant risk to the tanner. The T35-LED Module is comprised of Nichia Chip-Type LEDs (Model NCSU033A), a power connector, a fuse, and a 700 mA nominal current regulator. The T35-LED Module (Model 3N33X1) is clearly marked with a recommended lifetime of 10,000 hours. The T35 is powered by low-voltage DC power (13 ± 0.5 VDC, 12 ± 0.1 VDC, - 12 ± 0.1 VDC) and low-voltage DC-DC converters located in the bench of the tanning chamber with redundant fans for cooling. T35 LED Modules are replaceable by TanThera certified technicians only. The T35 has a nominal peak wavelength output of 365nm and a maximum tanning session of 35 minutes. The total tanning chamber output less than 1250 W of UVA 1 light. An industry de-facto standard T-Max® timer regulates the session. The T35 incorporates a manual session termination switch that allows a tanner to discontinue a session at any time.
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