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510(k) Data Aggregation

    K Number
    K242977
    Device Name
    308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Cleared
    2025-02-06

    (133 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xuzhou Kernel Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    308nm Excimer Phototherapy Device is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
    Device Description
    Ultraviolet phototherapy originated in the 1920s. Due to the development of science and technology, the technology of artificial light source has developed rapidly. UVB therapy, as a representative, has become one of the effective methods to treat various skin diseases in developed countries such as Europe and America.
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    K Number
    K222751
    Device Name
    LED Light Therapy Device, KN-7000L
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Cleared
    2023-02-01

    (142 days)

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

    Xuzhou Kernel Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light (633±10mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain. arthritis and musele spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The LED Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10mm), yellow light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm). The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light). The instrument is mainly composed of a main frame, an irradiator, and a lifting stand.
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    K Number
    K200971
    Device Name
    308nm Excimer System
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Cleared
    2020-12-15

    (246 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xuzhou Kernel Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
    Device Description
    The proposed device, 308nm Excimer System is a new type of ultraviolet light therapy instrument, which could emit high levels of UV light. It has the following features: - High intensity UV light. - The instrument is suitable for small area treatment with good targeting. - 8 inches Super Large color touch LCD screen which make the operation display more convenient; - Manual MED tests can also be performed according to the skin characteristics of the patient. - One-click Control light source Output. - Powerful user management capabilities. - Can realize the export and view of user information; - Multi-spec treatment handle light filter. The user can choose filter according to the size of the treatment area. Avoid excess radiation output. - Fingerprint entry makes it easy for doctors to quickly access patient information (for KN-5000D): - Accurate calibration system. Enhanced reliability of instrument dose output (KN-5000D applicable).
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    K Number
    K200929
    Device Name
    Hair Growth System
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Cleared
    2020-06-03

    (57 days)

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

    Xuzhou Kernel Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
    Device Description
    The Hair Growth System (Model: KN-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished. The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A. For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.
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    K Number
    K190685
    Device Name
    Hair Growth System
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Cleared
    2019-07-26

    (130 days)

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

    Xuzhou Kernel Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The Hair Growth System Model: KN-8000A is a transportable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. It produces a red light, diode lasers operating at a 650-nanometer wavelength (maximum output power of each is 5 mW). The device mainly includes a host machine, light source and lifting bracket. The light source applicator was equipped with the access sensor device, it can power off the light source when the patient's scalp deviates from the work area.
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    K Number
    K181805
    Device Name
    UV Phototherapy
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., LTD.
    Date Cleared
    2019-01-11

    (189 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xuzhou Kernel Medical Equipment Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UV Phototherapy is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
    Device Description
    The proposed device is a hand held ultraviolet phototherapy device, intended for partial treatment excluding eyes. Irradiation time can be adjusted from 0~30min and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in sixteen specifications. The device model KN-4003AL2S, KN-4003BL2S, KN-4003AL2DS, KN-4003BL2DS, KN-4006AL1S, KN-4006BL1S, KN-4006AL1DS and KN-4006BL1DS are designed with SD card. The recommended treatment can be written into the SD card by a physician. The device can be used in hospitals, clinics and households.
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    K Number
    K132643
    Device Name
    UV PHOTOTHERAPY
    Manufacturer
    XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
    Date Cleared
    2014-01-30

    (157 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UV phototherapy, model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006, delivers ultraviolet (UV) light to targeted affected skin. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
    Device Description
    The UV Radiation Treatment System model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006 delivers ultraviolet (UV) light to targeted affected skin, via Fluorescent UV lamps. It is a Stationary base unit with hand held therapy wand or hand held device.
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