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510(k) Data Aggregation

    K Number
    K211994
    Manufacturer
    Date Cleared
    2021-07-28

    (30 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BRAUN Silk.expert Mini Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Mini 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 Mini, a hair removal device. It primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria.

    Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. The document confirms the device's clearance for "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," but it does not elaborate on the specific study details that validated this claim.

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