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510(k) Data Aggregation

    K Number
    K220168
    Device Name
    Skin Care Beauty Mask (Model: MJ-06)
    Manufacturer
    Shenzhen Kaiyan Medical Co Ltd
    Date Cleared
    2022-05-17

    (117 days)

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

    Shenzhen Kaiyan Medical Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.
    Device Description
    The Skin Care Beauty Mask (Model: MJ-06) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Skin Care Beauty Mask can emit two different kinds of wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are 150 LED lights with a center wavelength of 465nm and 150 LED lights with a center wavelength of 640nm, and the energy provided by each mode is 30mw/cm2 . The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 5-minute treatment or 10-minute treatment selected.
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    K Number
    K213024
    Device Name
    Oren LED Perioral Light Therapy System
    Manufacturer
    Shenzhen Kaiyan Medical Co Ltd
    Date Cleared
    2021-12-22

    (92 days)

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

    Shenzhen Kaiyan Medical Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.
    Device Description
    The Oren LED Perioral Light Therapy System (Model: OR-01) is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device contains four types of LEDs: 605nm amber, 630m red, 660nm red, and 880nm infrared. The Oren LED Perioral Light Therapy System components include the main device, Charging base, power cord, adapter. There are two buttons on the top edge of the main unit, Power button and Shutdown button. This device Only has one treatment modes. The Oren LED Perioral Light Therapy System is applied directly to the skin to ensure consistent administration of light during each treatment. The device is sold as Over the Counter (OTC).
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    K Number
    K203214
    Device Name
    DemarkQ WOW, DemarkQ POP
    Manufacturer
    Shenzhen Kaiyan Medical Co Ltd
    Date Cleared
    2021-07-22

    (262 days)

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

    Shenzhen Kaiyan Medical Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
    Device Description
    The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) are over-the counter light emitting diode (LED) panel device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The devices use two types of LEDs: 630nm red and 415nm blue. The device operated only by one key, both wavelengths will be emitted at the same time when it be turned on. The treatment time is controlled by the user. There are no user settings or adjustments required. The device's components include the main device which containing the LED treatment module, USB power cord and goggles.
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    K Number
    K203271
    Device Name
    Aduro light therapy Handheld
    Manufacturer
    Shenzhen Kaiyan Medical CO LTD
    Date Cleared
    2021-07-21

    (257 days)

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

    Shenzhen Kaiyan Medical CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aduro light therapy Handheld (Model:HD-03A,HD-25A,HD-07A),the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the mild to moderate inflammatory acne.
    Device Description
    Aduro light therapy Handheld (Model: HD-03A, HD-25A, HD-07A)
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    K Number
    K202390
    Device Name
    Aduro Light Beauty Mask
    Manufacturer
    Shenzhen Kaiyan Medical Co Ltd
    Date Cleared
    2021-07-14

    (327 days)

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

    Shenzhen Kaiyan Medical Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For MK-660, MK-66USBO, MK-020: The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne. For MK-66USBA, MK-02A: The Aduro Light Beauty Mask (Model: MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face. For MK-66USBB, MK-02B: The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
    Device Description
    For MK-660, MK-66USBO, MK-02O: The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Aduro Light Beauty Mask can emit light with two different center wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are a total of 66 LEDs to provide power intensity of about 30mw/cm2. The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment. For MK-66USBA, MK-02A: The Aduro Light Beauty Mask (Model: MK-62A) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the blue light (465nm) which is intended to help reducing the appearance of mild to moderate inflammatory acne. There are a total of 66 LEDs to provide power intensity of about 30mw/cm². The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment. For MK-66USBB, MK-02B: The Aduro Light Beauty Mask (MK-66USBB, MK-02B) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the red light (640nm) which is intended to improve the appearance of wrinkles. There are a total 66 LEDs to provide power intensity of about 30mw/cm². The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.
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