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

    Wound Treatment System (VHT-200)

    K Number: K250188 · Decision Mar 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    47

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    Basic Information

    Device Name
    Wound Treatment System (VHT-200)
    K Number
    K250188
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vaporox, Inc.
    Date Received
    January 22, 2025
    Decision Date
    March 10, 2025
    Product Code
    KPJ
    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
    KPJ Chamber, Oxygen, Topical, Extremity

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    Other Clearances by Vaporox, Inc.

    K Number Device Name
    K212121 VHT-200 Wound Treatment System