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510(k) Data Aggregation

    K Number
    K231749
    Device Name
    Radio Frequency System
    Date Cleared
    2023-10-19

    (126 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhenshi Sincoheren S&T Development Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Radio Frequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The Radio Frequency System consists of a host with an LCD touch screen control panel, moving base, treatment handle and pedal switch. The treatment handle includes a handpiece and a sterilized tip. And the sterilized tip is classified into two type, microneedle electrodes and RF electrodes. The treatment parameters are entered via the touchscreen control panel that also displays system output information during treatment. Microneedle electrodes come in light contact with the epidermis of the patient and minimally penetrate the epidermis while RF electrodes not penetrate. RF POWER, ON TIME (RF POWER×ON TIME = RF Energy), DEPTH, are user-selectable via the control panel. The RF Power output is controlled to insure for a given time that a determinate RF Energy is delivered to the bipolar electrodes. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the electrodes.
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    K Number
    K231894
    Device Name
    LED Spectrum therapy instrument
    Date Cleared
    2023-09-20

    (84 days)

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

    Shenzhenshi Sincoheren S&T Development Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, PDT-M. PDT-I: Blue (420±10m) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Red (630±10mm) and Blue (420±10mm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-J: Combination of Yellow (590±10mm) and Infrared (825±10nm) is intended to emit energy in the IR and visible 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 stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-K: Blue (420±10mm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10mm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-L: Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-M: Combination of Yellow (590±10mm) and Infrared (825±10nm) is intended to emit energy in the IR and visible 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 stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The LED Spectrum therapy instrument is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs). The device produces light in the following regions of the light spectrum: - Red (630±10nm) . - Blue (420±10nm) . - . Yellow (590±10nm) - . Infrared (825±10nm) This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.
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