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510(k) Data Aggregation

    K Number
    K232056
    Device Name
    IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
    Manufacturer
    Dongguan Lide Electric Appliance Co., Ltd
    Date Cleared
    2023-10-06

    (87 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K213041,K192432
    Why did this record match?
    Device Name :

    IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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 (Model: PB1, PB2, PB3, PB4, TM002), is an over-the-counter, homeuse and personal device for hair reduction 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 indications for use, performance, structure design and operation of these five models of the device are basically the same, there is only a minor difference in appearance and physical dimension. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product is equipped with a skin sensor to detect appropriate skin contact, if the flash window of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

    AI/ML Overview

    The provided text describes the FDA 510(k) clearance for an IPL Hair Removal Device. However, it does not contain the information necessary to describe acceptance criteria for an AI/CADe device, nor a study proving it meets those criteria.

    The document discusses:

    • The FDA clearance process for a medical device (specifically, an IPL hair removal device).
    • Comparison of the device to predicate devices based on technical specifications (e.g., energy density, wavelength, power supply).
    • Non-clinical performance data, primarily focusing on safety testing such as biocompatibility, electrical safety, electromagnetic compatibility (EMC), eye safety, software verification and validation, and usability.

    There is no mention of an AI/CADe component in this device, nor any study or data related to diagnostic performance, ground truth, expert readers, or statistical measures like sensitivity, specificity, or AUC.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/CADe device meets those criteria based solely on the provided text. The document pertains to a physical IPL hair removal device and its safety/performance testing, not an AI-powered diagnostic tool.

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