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510(k) Data Aggregation

    K Number
    K243072
    Device Name
    Préime DermaFacial (MicroT)
    Manufacturer
    EMA Aesthetics, LTD
    Date Cleared
    2025-04-01

    (186 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Préime DermaFacial (MicroT)

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

    The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided FDA 510(k) clearance letter for the Préime DermaFacial (MicroT) device does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

    This type of FDA clearance letter primarily states that the device has been found substantially equivalent to a predicate device and outlines regulatory obligations. It does not typically detail the specific performance studies, acceptance criteria, or expert qualifications that were submitted as part of the 510(k) application.

    To answer your questions, I would need to access the full 510(k) submission document or a summary of safety and effectiveness, which is not included in the provided text.

    Therefore, I cannot provide the requested table and detailed information based solely on this document.

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