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510(k) Data Aggregation

    K Number
    K222377
    Device Name
    Led Mask Platinum Md
    Manufacturer
    CellReturn Co., LTD.
    Date Cleared
    2022-11-03

    (90 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CellReturn Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LED MASK PLATINUM MD is an over the counter device that is indicated for the treatment of full face wrinkles.
    Device Description
    This product irradiates the skin with red light in the wavelength range of 630 to 690 nm and infrared light in the wavelength range of 820 to 880 nm. Treatment of wrinkles all over the face. This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
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