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510(k) Data Aggregation

    K Number
    K242604
    Device Name
    Helios+ UV-C System
    Date Cleared
    2025-05-27

    (270 days)

    Product Code
    Regulation Number
    880.6510
    Why did this record match?
    Product Code :

    QXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.
    Device Description
    Surfacide Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. Helios+ delivers a defined dose to a defined distance and area sufficient for 2-log microbial reduction of vegetative bacteria and Clostridioides difficile spores. Helios+ is used in operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present. Helios+ includes 1-3 UV-C emitters, 1-3 safety sensors, a control tablet, and 2 joiners that link the emitters for transport and serve as warning stands when the device is in use. Simultaneous use of multiple UV-C emitters can reduce shadowed areas by providing multiple direct lines of sight to non-critical medical device surfaces.
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    K Number
    DEN230007
    Device Name
    LightStrike+ (MXSUV1-SL and MXSUV1-FT)
    Date Cleared
    2023-09-01

    (212 days)

    Product Code
    Regulation Number
    880.6510
    Why did this record match?
    Product Code :

    QXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Xenex LightStrike™+ is a pulsed, broad-spectrum, high-intensity, germicidal UV light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. LightStrike+ is intended for use in unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.
    Device Description
    LightStrike+ is a system that emits UV germicidal light to reduce the microbial load present on non-porous, non-critical medical device surfaces in healthcare environments, after manual cleaning and disinfection practices. Designed for microbial reduction cycles, the system will achieve the labeled log reductions through the utilization of Xenon lamp technology for the generation of UV germicidal light in the system's intended use environments. It is designed to be moved to targeted locations within a facility. The graphical user interface allows operators (trained cleaning staff) to select preprogrammed rooms and their associated protocols for cycle execution. The system is for use in unoccupied areas and includes design and redundant safety features to help prevent accidental exposure to the UV light.
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