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510(k) Data Aggregation

    K Number
    K233010
    Device Name
    Beagank 4T Plus
    Manufacturer
    Belega Inc.
    Date Cleared
    2023-11-21

    (60 days)

    Product Code
    NFO, GYB
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Belega Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
    Device Description
    The BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS: Scalp attachment, Small attachment.
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