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510(k) Data Aggregation

    K Number
    K253666

    Validate with FDA (Live)

    Date Cleared
    2026-02-23

    (94 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 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 amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

    Device Description

    The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user.

    The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T31A, T32A)

    The Intense Pulsed Light technology works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is not the external adapter and its IPL emission activation is by finger switch. The device contains a Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission. It is designed with dual lamps that work together and can emit multipulses per shot.

    In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

    The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is constructed with sapphire, and does not affect the irradiated area (spot size) of the light outlet.

    AI/ML Overview

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