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

    Hair Growth Comb (SZ-23,SZ-23A)

    K Number: K241342 · Decision Nov 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    5
    Review Days
    179

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Hair Growth Comb (SZ-23,SZ-23A)
    K Number
    K241342
    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 Nuon Medical Equipment Co., Ltd.
    Date Received
    May 13, 2024
    Decision Date
    November 8, 2024
    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 Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    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
    View all

    Other Clearances by Shenzhen Nuon Medical Equipment Co., Ltd.

    K Number Device Name
    K251034 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
    K242151 Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
    K242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
    K241155 Cold Sore Device (QPZ-03)