BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    LightStrike+ (MXSUV1-SL and MXSUV1-FT)

    K Number: DEN230007 · Decision Sep 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    212

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    Basic Information

    Device Name
    LightStrike+ (MXSUV1-SL and MXSUV1-FT)
    K Number
    DEN230007
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.6510
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Xenex Disinfection Services, Inc.
    Date Received
    February 1, 2023
    Decision Date
    September 1, 2023
    Product Code
    QXJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QXJ Whole Room Microbial Reduction Device

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