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

    WinForth (LM-E470KA)

    K Number: K250916 · Decision Aug 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    7
    Review Days
    140

    Basic Information

    Device Name
    WinForth (LM-E470KA)
    K Number
    K250916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Leaflife Technology Co., Ltd.
    Date Received
    March 27, 2025
    Decision Date
    August 14, 2025
    Product Code
    PBX
    Advisory Committee
    General, Plastic Surgery
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    Similar 510(k) Clearances

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

    SPECCHIO

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Apollo Quattro (APQ-10M)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NeoSculpt Plus

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OptiLUV Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Zionic Pro Max (Radiofrequency)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEBE (NP0000763)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Shenzhen Leaflife Technology Co., Ltd.

    K Number Device Name
    K253219 LeafPure-Echo (LM-LPNdA)
    K233760 Mjolnir Pro. (Multi–electrode plasma)
    K230362 Planar LED mate
    K220103 LED Therapy Device (Planar LED/Planar LED mini)
    K212697 Leaf Smooth
    K202980 Laser Therapy Device