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

    Erchonia EVRL

    K Number: K251843 · Decision Sep 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    26
    Review Days
    88

    Basic Information

    Device Name
    Erchonia EVRL
    K Number
    K251843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erchonia Corporation
    Date Received
    June 16, 2025
    Decision Date
    September 12, 2025
    Product Code
    OLP
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

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    Other Clearances by Erchonia Corporation

    K Number Device Name
    K251903 Erchonia DPN Laser (Model# EVRL)
    K252574 Erchonia CLX (Model # CFL)
    K243811 Erchonia Zerona® VZ8
    K231409 Erchonia FX-405
    K231474 Erchonia Violet ZERONA® Z6 OTC
    K221987 Erchonia GVL
    K220519 Erchonia Zerona Z-Bed
    K212595 Erchonia FX-405
    K211186 Erchonia XLR8
    K192544 Erchonia Emerald
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