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

    Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)

    K Number: K260899 · Decision Jun 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    90

    Basic Information

    Device Name
    Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
    K Number
    K260899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zdeer Technology (Henan) Co., Ltd.
    Date Received
    March 18, 2026
    Decision Date
    June 16, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OAP), ordered by most recent decision date.

    Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Alma TED+ System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

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

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

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

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Hair Growth Laser Cap

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Zdeer Technology (Henan) Co., Ltd.

    K Number Device Name
    K260452 Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)