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510(k) Data Aggregation

    K Number
    K190366
    Device Name
    BRAUN Silk Expert Pro 3
    Manufacturer
    CyDen Limited
    Date Cleared
    2019-03-18

    (31 days)

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

    BRAUN Silk Expert Pro 3

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

    The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the BRAUN Silk.expert Pro 3 Hair Removal Device, Model 6032. It does not contain the detailed information about acceptance criteria, study design, or performance metrics that would be expected in a clinical study report or a more comprehensive summary of safety and effectiveness data.

    Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the device is cleared for marketing based on substantial equivalence, and it specifies the Indications for Use. However, it does not include the detailed scientific evidence that supports these indications.

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