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510(k) Data Aggregation

    K Number
    K232795
    Device Name
    Led Mask Platinum Exclusive MD
    Manufacturer
    STG24 CO.,LTD.
    Date Cleared
    2023-12-07

    (86 days)

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

    STG24 CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light and infrared light and treat mild to moderate acne vulgaris of the face.
    Device Description
    The LED MASK EXCLUSIVE MD is an over the counter device that is intended for the treatment of full face wrinkles with red light and infrared light and mild to moderate acne with blue light. This product irradiates the skin with blue light in the wavelength range of 400 ~ 440mm, red light in the wavelength range of 630 ~ 690mm, and infrared light in the wavelength range of 820 ~ 880mm. 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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