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510(k) Data Aggregation

    K Number
    K242385
    Device Name
    LED Therapy Mask (MN1, M226)
    Manufacturer
    Shenzhen Borria Technology Co., Ltd
    Date Cleared
    2025-04-07

    (238 days)

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

    Shenzhen Borria Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Red light: Treatment of full- face wrinkles. Blue light (only suitable model M226 and MN1 LED Facial Mask): Treatment of mild to moderate inflammatory acne. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of full face wrinkles.
    Device Description
    The subject device LED Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrowband of light for the treatment of cosmetic indications including facial wrinkles and acnes. The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and Type-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.
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    K Number
    K232939
    Device Name
    IPL Hair Removal Device
    Manufacturer
    Shenzhen Borria Technology Co., Ltd
    Date Cleared
    2023-12-15

    (86 days)

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

    Shenzhen Borria Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    The subject device IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. There are BR223, BR225 two models in this application. Their work principle, function, intended use, structure, and composition are the same, with difference being product appearance, but this difference does not affect or change the intended use of the device.
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