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510(k) Data Aggregation

    K Number
    K231800
    Device Name
    IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2023-09-07

    (79 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K220669,K214113,K223618
    Why did this record match?
    Device Name :

    IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

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

    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 a personal, light-based, home-use hair reduction device intended to be sold over-the-counter. The device provides hair reduction by using Intense Pulsed Light (IPL) technology. 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 (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

    The device includes JP1, JR3, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.

    AI/ML Overview

    This FDA 510(k) summary describes the substantial equivalence of the "IPL Hair Removal Device" to predicate devices, focusing on the safety and efficacy for its intended use. It does not contain information about acceptance criteria and performances of an AI/ML powered device.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI component.

    The document primarily addresses:

    • Device Description: An over-the-counter IPL device for hair removal.
    • Comparison to Predicate Devices: Demonstrates similar intended use, technology, and operational characteristics to previously cleared devices.
    • Performance Data (Non-Clinical):
      • Biocompatibility Testing: Conducted in accordance with ISO 10993 standards (ISO 10993-5, ISO 10993-10, ISO 10993-23) to assess cytotoxicity, irritation, and skin sensitization. All tests were passed.
      • Electrical Safety and EMC: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83 standards. All tests were passed.
      • Eye Safety: Tested against IEC 62471.
      • Software Verification and Validation: Submitted documentation consistent with a moderate level of concern, demonstrating that all software requirements are met and hazards mitigated.
      • Usability: Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."

    The conclusion states that based on this non-clinical data, the device is as safe and effective as the legally marketed predicate devices.

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