BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

    K Number: K253669 · Decision Jan 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    23
    Review Days
    63

    Basic Information

    Device Name
    TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
    K Number
    K253669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Received
    November 21, 2025
    Decision Date
    January 23, 2026
    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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