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

    SOLIUS PRO UVB Light Panel

    K Number: K252960 · Decision Jan 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    122

    Basic Information

    Device Name
    SOLIUS PRO UVB Light Panel
    K Number
    K252960
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solius Labs, Inc.
    Date Received
    September 16, 2025
    Decision Date
    January 16, 2026
    Product Code
    SGZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SGZ Ultraviolet Lamp Products