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510(k) Data Aggregation

    K Number
    K243993
    Device Name
    Photon Therapy Apparatus (BL-10)
    Date Cleared
    2025-03-13

    (77 days)

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

    Xemis Medical Technology (Shenzhen) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Photon therapy apparatus 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±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (830±8mm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The photon therapy apparatus (BL-10) use 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±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm). The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources.
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