BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Hair Regrowth Cap (Model: T-119-HRC)

    K Number: K253349 · Decision Dec 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    13
    Review Days
    85

    Basic Information

    Device Name
    Hair Regrowth Cap (Model: T-119-HRC)
    K Number
    K253349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Tree Ventures Europe B.V.
    Date Received
    September 30, 2025
    Decision Date
    December 24, 2025
    Product Code
    OAP
    Advisory Committee
    Physical Medicine
    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
    OAP Laser, Comb, Hair

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