Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152423
    Device Name
    Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
    Date Cleared
    2016-05-20

    (268 days)

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

    Sunfire Industries Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used for the tanning of Human Skin.
    Device Description
    The Sunfire series of tanning beds is available in four configurations; a 32 lamp configuration that contains sixteen 71 inch fluorescent UV lamps in its canopy section and sixteen 71 inch fluorescent UV lamps in its bench sections, a 24 lamp configuration that contains twelve 71 inch fluorescent UV lamps in its canopy section and twelve 71 inch fluorescent UV lamps in its bench sections, a 16 lamp configuration that contains eight 71 inch fluorescent UV lamps in its canopy section and eight 71 inch fluorescent UV lamps in its bench sections, and a 12 lamp canopy only configuration that contains twelve 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with lamps horizontally arranged in a manner so that they are equidistant from the tanner. The user of the Sunfire 32, 24 and 16 units lies down on the bench section and pulls down the canopy section, which is counterweighted by gas springs so that it can pivot and remain at any angle. The user of the Sunfire 12R lies down on a cot or bed and positions the Sunfire 12R canopy over their body. The lamps are powered by electronic type ballasts. The duration of exposure is controlled by a user settable electronic timer or alternatively an electromechanical timer. The session time can be set to any value called for on the recommended exposure schedule. Session time cannot be set longer than the maximum recommended exposure schedule time. A backup timer is provided that ensures the bed's lamps cannot operate longer than the maximum recommended exposure. A stop switch or knob is provided to immediately turn off the UV lamps if needed.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1