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

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

    K Number: K252414 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    23
    Review Days
    90

    Basic Information

    Device Name
    Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
    K Number
    K252414
    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
    August 1, 2025
    Decision Date
    October 30, 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

    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

    Hair Growth Laser Cap

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

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

    K Number Device Name
    K254025 LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
    K260688 Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
    K260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
    K253878 LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
    K252603 HIGHERDOSE Body Sculptor (Model: GS-03)
    K253669 TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
    K252272 ORA Method LED Gua Sha (GS-04)
    K251781 KALA MINI 2.0 (KALA-04)
    K251012 TRUDERMAL Pro (ZLD-390)
    K250761 KALA Therapy Wand (Model: KALA-03)
    Search all 23 clearances from Shenzhen Kaiyan Medical Equipment Co., Ltd. →