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510(k) Data Aggregation

    K Number
    K200983
    Device Name
    Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
    Manufacturer
    Ningbo Hesi Electric Co., Ltd
    Date Cleared
    2021-07-14

    (456 days)

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

    Ningbo Hesi Electric Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face writtles. The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles - The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stifficess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
    Device Description
    LED FACIAL LIGHT THERAPY MASK (Model: HK207) is a home use wearable LED phototherapy device designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. The red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles. FLEXIBLE LED LIGHT THERAPY (Model: HK209) is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the near-infrared region of the spectrum (880nm) intended to provide topical heating to temporary pain relief. Blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.
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