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

    Helios+ UV-C System

    K Number: K242604 · Decision May 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    270

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Helios+ UV-C System
    K Number
    K242604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6510
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Preventamed Technologies, Inc. Dba Surfacide Manufacturing
    Date Received
    August 30, 2024
    Decision Date
    May 27, 2025
    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

    Similar 510(k) Clearances

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

    LightStrike+ (MXSUV1-SL and MXSUV1-FT)

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