LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213830
    Device Name
    Home use hair removal device, model: Precise Touch Pro
    Manufacturer
    Iluminage Beauty Co., Limited
    Date Cleared
    2022-02-01

    (55 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K203510,K173813
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

    Device Description

    The Precise Touch Pro Home use 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 to perform hair removal. The device mainly consists of IPL main body, AC adapter and device stand three parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria related to medical effectiveness (e.g., hair reduction efficacy percentages).

    The document is a 510(k) summary for a home-use hair removal device (Precise Touch Pro) and focuses on demonstrating substantial equivalence to predicate devices, not on proving de novo clinical efficacy against specific acceptance criteria.

    The "Performance Data" section primarily addresses:

    1. Biocompatibility Testing: Ensuring the materials are safe for body contact.
    2. Electrical Safety and Eye Safety: Compliance with relevant international standards.
    3. Software Verification and Validation: Assuring software functions correctly and mitigates risks.

    These are safety and engineering performance aspects for regulatory compliance, not efficacy performance related to the device's intended use of hair removal in terms of, for example, a targeted percentage reduction in hair.

    Therefore, I cannot provide the requested information regarding acceptance criteria for device performance and a study proving it, as that information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1