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510(k) Data Aggregation

    K Number
    K252642

    Validate with FDA (Live)

    Device Name
    Microcurrent Facial Device (CEC101, EEI101)
    Manufacturer
    Shenzhen Dachi Communication Co., Ltd.
    Date Cleared
    2025-11-19

    (90 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K232795,K242385,K241718,K223919
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CEC101:
    Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.

    The light treatment of Microcurrent Facial Device is indicated for:

    • Red light is intended for the treatment of facial wrinkles.
    • Blue light is intended for the treatment of mild to moderate inflammatory acne.

    EEI101:
    Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.

    The light treatment of Microcurrent Facial Device is indicated for:

    • Red light is intended for the treatment of facial wrinkles.
    • Blue light is intended for the treatment of mild to moderate inflammatory acne.
    • Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne.
    Device Description

    The Microcurrent Facial Device probe is designed for optimal contact with the face. The device has two different microcurrent modes that differ in how the probe switches. Users can adjust settings for personalized comfort by pressing the mode button. The microcurrent mode intensity starts from (0) to (9).(Cleared under K244004)

    The device also outputs blue light with the wavelength of 415+/-10nm and red light with the wavelength 622+/-10nm and delivers to the skin of the face to achieve the therapeutic effects，such as improving mild to moderate acne on the face.

    The Microcurrent Facial Devices unit contains a main board and a rechargeable battery. The enclosure is made of medical-grade biocompatible plastic and the probe is made of irregularly shaped stainless steel.

    Model CEC101 have "Phototherapy mode", "CLEANING mode","PENETRATION mode", "LIFTING mode" and "COOL mode" five modes. The "CLEANING mode","PENETRATION mode", "LIFTING mode" and "COOL mode" modes have cleared under K244004.

    Model EEI101 have "Phototherapy mode", "Face mode", "Neck mode", and "Body mode" four modes. The "Face mode", "Neck mode", and "Body mode" have cleared under K244004.

    AI/ML Overview

    N/A

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