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510(k) Data Aggregation

    K Number
    K250942
    Device Name
    Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-07-11

    (105 days)

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

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250938
    Device Name
    Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-05-23

    (56 days)

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

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
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    K Number
    K243749
    Device Name
    Jmoon Conductive Gel
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-04-08

    (124 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity.
    Device Description
    The Jmoon Conductive Gel is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
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    K Number
    K243393
    Device Name
    JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-02-03

    (95 days)

    Product Code
    NFO, OHS
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use. JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.
    Device Description
    Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle. The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.
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    K Number
    K243492
    Device Name
    Ulike Reglow Light Therapy Device (UM10)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-01-10

    (59 days)

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

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.
    Device Description
    Ulike Reglow Light Therapy Device adopts light emitting diodes (LED) in the 630mm ± 10nm,830nm ± 10nm,590mm±10nm and 465nm±10nm spectrum to irradiate on the face to realize its therapeutic effect. The Ulike Reglow Light Therapy Device adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode. Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. To prevent irradiation of LED lights to eyes during the treatment, Ulike Reglow Light Therapy Device has incorporated protective eye-shield which blocks light energy from LEDs.
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    K Number
    K241998
    Device Name
    Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2024-12-13

    (157 days)

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

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It has skin-safe detection. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
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    K Number
    K241205
    Device Name
    Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2024-09-09

    (132 days)

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

    Shenzhen Ulike Smart Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.
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