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510(k) Data Aggregation

    K Number
    K243587
    Device Name
    PureLift GLOW
    Manufacturer
    Xtreem Pulse LLC
    Date Cleared
    2025-03-06

    (106 days)

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

    Xtreem Pulse LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
    Device Description
    PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne. The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths. The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.
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    K Number
    K221443
    Device Name
    PureLift Pro Plus
    Manufacturer
    Xtreem Pulse LLC
    Date Cleared
    2022-10-21

    (156 days)

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

    Xtreem Pulse LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for facial stimulation and indicated for-over-the counter cosmetic use.
    Device Description
    The PureLift Pro Plus is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Plus probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (10). The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D). Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
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