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

    JOVS Electric Stimulation Beauty Device (JE2)

    K Number: K250227 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    263

    Basic Information

    Device Name
    JOVS Electric Stimulation Beauty Device (JE2)
    K Number
    K250227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Qianyu Technology Co., Ltd.
    Date Received
    January 27, 2025
    Decision Date
    October 17, 2025
    Product Code
    NFO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

    Similar 510(k) Clearances

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

    VITA Multi-Function Head Brush (TB-2343F, TB-2442F)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ulike Clear Zero (YC10 BU)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DeepSkin (DEP100)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aura Glide (FC40)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Medi Lift Essential Eye Mask

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Shenzhen Qianyu Technology Co., Ltd.

    K Number Device Name
    K244020 Wrinkle Treatment Device (JM1, JM2B)
    K240360 Wrinkle Treatment Device (JM2)
    K231800 IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
    K220645 Hand-held IPL device (JOVS Hair Removal Device)
    K214113 Hand-held IPL device(JOVS Graphene Hair Removal Device)