Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K230021
    Device Name
    IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
    Manufacturer
    Shenzhen Yangyi Technology ., Ltd
    Date Cleared
    2023-03-31

    (86 days)

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

    Shenzhen Yangyi Technology ., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    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 (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 and its IPL emission activation is by finger switch. The device contains a Xenon Quartz Lamp Tube to emit light and a skin sensor 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 trigger a pulse emitting. The IPL Hair Removal Device includes: AP10, AP20, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.
    Ask a Question

    Page 1 of 1