BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)

    K Number: K250642 · Decision Nov 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    22
    Review Days
    260

    Basic Information

    Device Name
    LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
    K Number
    K250642
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huizhou Foryou Medical Devices Co., Ltd.
    Date Received
    March 4, 2025
    Decision Date
    November 19, 2025
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Huizhou Foryou Medical Devices Co., Ltd.

    K Number Device Name
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    K223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
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