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

    Focal One®

    K Number: K251910 · Decision Nov 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    152

    Basic Information

    Device Name
    Focal One®
    K Number
    K251910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4340
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edap Technomed, Inc.
    Date Received
    June 20, 2025
    Decision Date
    November 19, 2025
    Product Code
    PLP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PLP High Intensity Ultrasound System For Prostate Tissue Ablation

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    Other Clearances by Edap Technomed, Inc.

    K Number Device Name
    K172721 FOCAL ONE
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