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510(k) Data Aggregation

    K Number
    K244020
    Device Name
    Wrinkle Treatment Device (JM1, JM2B)
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2025-05-01

    (125 days)

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

    Shenzhen Qianyu Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
    Device Description
    The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the device onto the face. This light is generated by VCSEL (Vertical-cavity surface-emitting laser) with two different spectrum wavelengths: red (660nm) and infrared (850nm). Model JM1 is controlled directly by the button on the main mask body, which can realize device's power on/off and mode switch. The device will automatically shut down when the treatment time is over or when the pure water is run out. Model JM2B is controlled by a controller that is connect to the main unit and the device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over. Both models are powered by rechargeable Li-battery.
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    K Number
    K240360
    Device Name
    Wrinkle Treatment Device (JM2)
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2024-04-05

    (59 days)

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

    Shenzhen Qianyu Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wrinkle treatment device (model: JM2) is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
    Device Description
    The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the face. This light is generated by LED with two different spectrum wavelengths: red (660nm) and infrared (850nm). The device is powered by rechargeable Li-battery and controller that is connect to the main unit. The device's power-on/ off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
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    K Number
    K231800
    Device Name
    IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2023-09-07

    (79 days)

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

    Shenzhen Qianyu Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    IPL Hair Removal Device is a personal, light-based, home-use hair reduction device intended to be sold over-the-counter. The device provides hair reduction by using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes JP1, JR3, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.
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    K Number
    K220645
    Device Name
    Hand-held IPL device (JOVS Hair Removal Device)
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2022-04-27

    (54 days)

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

    Shenzhen Qianyu Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
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    K Number
    K214113
    Device Name
    Hand-held IPL device(JOVS Graphene Hair Removal Device)
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2022-03-28

    (88 days)

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

    Shenzhen Qianyu Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    The Hand-held IPL device (JOVS Graphene Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
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