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510(k) Data Aggregation

    K Number
    K253881

    Validate with FDA (Live)

    Date Cleared
    2025-12-29

    (25 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intense Pulsed Light (IPL) System is an over-the-counter device intended for removal of unwanted body hair.

    Device Description

    Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) are a small over-the-counter device for the removal of hair growth based on 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 power adapter and its IPL emission activation is by a switch or auto light emission.

    Intense Pulsed Light (IPL) System, all models, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

    Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

    All models have single pulse, dual pulse and three pulse functions.

    The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

    The device is intended to be used for adults aged over 18.

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    K Number
    K253754

    Validate with FDA (Live)

    Date Cleared
    2025-12-23

    (28 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    18 - 65
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It 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

    Philips Lumea IPL is an Intense Pulsed Light (IPL) device intended for removal of unwanted hair. The device is to be used by persons in the age range of 18-65 years with fair up to medium brown skin tones, and naturally dark blond, brown, dark brown and black hair.

    The Philips Lumea IPL applies spectrally adjusted light to the user skin, which is absorbed by the melanin and after some applications hair sheds naturally and growth is delayed or inhibited.

    The Philips Lumea IPL is an Over-the-counter hand-held device powered by a wall mount adapter. It is provided in a non-sterile state and intended to be used by single person for multiple uses in homecare environment.

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    K Number
    K253304

    Validate with FDA (Live)

    Date Cleared
    2025-11-25

    (57 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 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 an over-the-counter, home-use device for unwanted hair removing by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model: KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain.

    The device is only powered by the external power adapter and its IPL emission activation is by finger switch or auto flash mode.

    The IPL Hair Removal Device has an irreplaceable flash window and it can cover an area of 3.0cm² for model KA-10, KA-11, KA-11C, KA-11D, and 3.3cm² for model KA-18, KA-20, KA-21, KA-21C, which is suitable for multiple hair removal areas, such as upper lip, armpit, bikini line, arms, legs, etc.

    The device contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the sapphire cooling function (Model: KA-18, KA-20, KA-21) and ice cooling function (Model: KA-10, KA-11, KA-11C, KA-11D), which will 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
    K253035

    Validate with FDA (Live)

    Date Cleared
    2025-11-19

    (58 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.

    Device Description

    The IPL Hair Removal Device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains of main unit, power adapter and protective goggles. The device contains a skin sensor to detect appropriate skin contact, if the light emitting window 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, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature by the Sapphire and provide the user with a better using experience. There are SYL001AZ and SYL002AZ two models in this application. Their work principle, function, intended use, structure, appearance and composition are the same, with the only difference in treatment level. The IPL Hair Removal Device has the components shown as following illustration:

    [Device diagram showing:

    • Air Inlet
    • Display Screen
    • Power On/Off Button
    • Flash Button
    • Light Emitting Window
    • Cold Compress Head
    • Air Outlet
    • Power Connection Port]
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    K Number
    K252618

    Validate with FDA (Live)

    Date Cleared
    2025-11-14

    (87 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 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 an over-the-counter, home-use device for unwanted hair removing by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model I6 S1, I6 D1 and I6 M1. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain.

    Model I6 S1 adopts single pulse technology, I6 D1 adopts dual pulse technology, and I6 M1 can switch between single pulse and dual pulse.

    The device is only powered by the external power adapter and its IPL emission activation is by finger switch or auto flash mode.

    The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.3cm² that is suitable for multiple hair removal areas, such as limbs, armpits, upper lip, back, chest, bikini area.

    The device contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the sapphire ice cooling function, which will 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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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    I PL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

    Device Description

    IPL Home Use Hair Removal Device is an over-the-counter, home-use, light based device for unwanted hair removal by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain.
    The device includes 21 models (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S), and the model name with an "S" indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit the treatment light pulses.

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    K Number
    K252209

    Validate with FDA (Live)

    Date Cleared
    2025-10-10

    (87 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IPL Home Use 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 Home Use Hair Removal Device 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.

    IPL Home Use Hair Removal Device includes five models, JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032. The five models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters. Models JD-TM016, JD-TM023 are single pulse devices while models JD-TM027, JD-TM028 and JD-TM032 are double pulses devices. The device is only powered by the external power adapter. This device adopts sapphire flash outlet that is suitable for multiple hair removal areas.

    The device is fitted with a skin sensor to detect appropriate skin contact, if the flash outlet of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. The device has a 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
    K251398

    Validate with FDA (Live)

    Date Cleared
    2025-10-02

    (149 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial 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 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.

    IPL Hair Removal Device includes two models, IPL-001 and IPL-002. The two models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters.

    The device is only powered by the external power adapter. This device adopts light exit window (the IPL-002 adopts sapphire light exit window) that is suitable for multiple hair removal areas. The device is fitted with a skin sensor to detect appropriate skin contact, if the light exit window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. Model IPL-002 has a cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 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.

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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IPL Hair Removal Device is an over-the counter device intended for removal of unwanted body hair. The device is used for adults with Fitzpatrick skin types I-IV.

    Device Description

    IPL Hair Removal Device is a small over-the-counter device for the permanent reduction of hair growth based on 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 IPL Hair Removal Device includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a finger switch or auto light emission. If the light outlet of the device is not fully contact with the skin, the device cannot emit the treatment light pulses. The device includes MLY-M011,MLY-M012,MLY-M013,MLY-M015,MLY-T001,MLY-T002 six models. There is difference in product appearance, cooling function, physical product dimension, indicator display and spot size, but their intended use, performance,output energy, structure design and operation are basically identical. MLY-M011 has no cooling function,while other models(MLY-M012,MLY-M013,MLY-M015,MLY-T001,MLY-T002) have cooling function.

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