BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    UV Smart D60

    K Number: K251354 · Decision Jan 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    274

    Basic Information

    Device Name
    UV Smart D60
    K Number
    K251354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6511
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UV Smart Technologies B.V.
    Date Received
    April 30, 2025
    Decision Date
    January 29, 2026
    Product Code
    SCS
    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
    SCS Ultraviolet Radiation Disinfection Chamber Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SCS), ordered by most recent decision date.

    Chronos®

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all