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510(k) Data Aggregation

    K Number
    K251984
    Device Name
    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co.,Ltd.
    Date Cleared
    2025-07-24

    (27 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251173
    Device Name
    Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
    Manufacturer
    Shenzhen Fansizhe Science and Technology Co., Ltd.
    Date Cleared
    2025-07-14

    (89 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    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?
    Product Code :

    OHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251000
    Device Name
    Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
    Manufacturer
    Shenzhen Chuangtong Yigou Technology Co., Ltd
    Date Cleared
    2025-06-30

    (90 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hand-held Hair Removal Device 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
    Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. The device 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 and its IPL emission activation is by finger switch. The Hand-held Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm² (Model BFZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) that is suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hand-held Hair Removal Device has the cooling function (suitable for model CT05, CT06, CT07, CT08, CT09), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
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    K Number
    K243036
    Device Name
    IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
    Manufacturer
    Bestway Plastic And Metal Products Ltd.
    Date Cleared
    2025-06-15

    (261 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device 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
    IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed twenty-three models with the same IPL technology for hair removal, which is model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL20, BHRL-21, BHRL-22. The device 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 and its IPL emission activation is by finger switch. The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6±0.25cm² (Model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL09, BHRL-10) and 2.7±0.25cm² (Model BHRL-05, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-06, BHRL-06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22) that is suitable for multiple hair removal areas, such as large areas (e.g. face, arms, legs) and small areas (e.g. armpits, bikini line). The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function (except model: BHRL-06B), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
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    K Number
    K250384
    Device Name
    IPL400
    Manufacturer
    EL Global Trade Ltd
    Date Cleared
    2025-05-23

    (101 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    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
    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?
    Product Code :

    OHT

    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
    K243017
    Device Name
    IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
    Manufacturer
    Foshan Newface Electronic Technology Co., Ltd.
    Date Cleared
    2025-05-06

    (221 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250253
    Device Name
    IPL Hair Removal Device (KCA511/KCA516/KCA522)
    Manufacturer
    Dongguan Boyuan Intelligent Technology Co.,Ltd
    Date Cleared
    2025-05-06

    (98 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    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 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
    IPL Hair Removal Device (Model: KCA511, KCA516,KCA522), is an over-the-counter, home-use and personal 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. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm² 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 cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience. IPL Hair Removal Device, model: KCA511, KCA516 and KCA522 have the same indication for use, performance, structure design and operation, the only deference is their appearance size and weight. IPL Hair Removal is used for removing excess facial hair and body hair and can also reduce hair regrowth. The products can be used on body parts such as underarm, bikini line, arms, facial hair below the chin line, back and legs. It is designed so that the flash window requires full contact with the skin to work (flash),it will no works as long as the flash window does not contact the skin.
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    K Number
    K250194
    Device Name
    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co.,Ltd.
    Date Cleared
    2025-03-26

    (62 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OHT

    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 oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain. The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
    Ask a Question

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