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

    Microcurrent Facial Device (CEC101, EEI101)

    K Number: K252642 · Decision Nov 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    90

    Basic Information

    Device Name
    Microcurrent Facial Device (CEC101, EEI101)
    K Number
    K252642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dachi Communication Co., Ltd.
    Date Received
    August 21, 2025
    Decision Date
    November 19, 2025
    Product Code
    OHS
    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
    OHS Light Based Over The Counter Wrinkle Reduction

    Similar 510(k) Clearances

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

    LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

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

    LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

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

    CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

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

    myLEDmask 2 (MJ-144)

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

    LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

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

    LED Light Therapy Masks (LumiLips FAC07NA)

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

    Other Clearances by Shenzhen Dachi Communication Co., Ltd.

    K Number Device Name
    K244004 Microcurrent Facial Device (CEC101, EE0101, EEI101)