LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032944
    Device Name
    YA-MAN LASER 21
    Manufacturer
    YA-MAN LTD
    Date Cleared
    2003-12-19

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    YA-MAN LASER 21

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

    The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or details about the training and test sets and their ground truth establishment.

    The document is an FDA 510(k) clearance letter for the "Laser 21" device, indicating that it has been deemed "substantially equivalent" to legally marketed predicate devices for the removal of unwanted hair in Fitzpatrick skin types I-IV.

    The letter focuses on regulatory approval and compliance, and does not contain the specifics of any performance studies or validation data that would typically be found in a study report. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or other study details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1