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510(k) Data Aggregation

    K Number
    K250308
    Device Name
    Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
    Manufacturer
    Dongguan Boyuan Intelligent Technology Co., Ltd.
    Date Cleared
    2025-04-29

    (85 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan Boyuan Intelligent Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet. Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles. Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.
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    K Number
    K241857
    Device Name
    LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
    Manufacturer
    Dongguan Boyuan Intelligent Technology Co., Ltd.
    Date Cleared
    2024-10-11

    (106 days)

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

    Dongguan Boyuan Intelligent Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KFB290, KFB291: Red light: Treatment of full-face wrinkles. 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. Red+Infrared Light: Treatment of full-face wrinkles. Amber light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne. KFB265, KFB293: Red+Infrared Light: Treatment of wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Amber light: Treatment of wrinkles.
    Device Description
    KFB290, KFB291: LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm). KFB 265, KFB 293: LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).
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