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510(k) Data Aggregation

    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)
    Date Cleared
    2025-07-14

    (89 days)

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

    Shenzhen Fansizhe Science and Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
    Device Description
    Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF, are 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 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. Intense Pulsed Light (IPL) System, models: T002AQ, T002AD, T002AF, contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, 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. Based on the dual pulse technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has single pulse and dual pulse functions. The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
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    K Number
    K223928
    Device Name
    Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
    Date Cleared
    2023-03-28

    (88 days)

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

    Shenzhen Fansizhe Science And Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
    Device Description
    Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are 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 device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission. Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. Intense Pulsed Light (IPL) System, models: T011C and T016K, 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: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, 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. The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
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    K Number
    K221569
    Device Name
    Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
    Date Cleared
    2022-06-30

    (30 days)

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

    Shenzhen Fansizhe Science And Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
    Device Description
    Intense Pulsed Light (IPL) System 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 Intense Pulsed Light (IPL) System 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 switch or auto light emission. Based on the ice-cool technology, the hair removal device with ice-cold compress functions.
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    K Number
    K212881
    Device Name
    Intense Pulsed Light (IPL) System
    Date Cleared
    2022-04-11

    (213 days)

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

    Shenzhen Fansizhe Science And Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
    Device Description
    Intense Pulsed Light (IPL) System, model: T012C
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