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510(k) Data Aggregation

    K Number
    K040081
    Device Name
    PALOMAR LUXV HANDPIECE
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2004-04-01

    (77 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041838,K021300,K002875
    Why did this record match?
    Reference Devices :

    K041838, K021300, K002875

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

    The EsteLuxTM System with the LuxVTM handpiece is intended for the treatment of inflammatory acne (acne vulgaris).

    Device Description

    The EsteLux Pulsed Light System with the LuxVTTM handpiece accessory is a light-based medical device designed for treatment of inflammatory acne.

    AI/ML Overview

    The provided text focuses on the 510(k) summary for the Palomar LuxV™ Handpiece, outlining its classification, intended use, and substantial equivalence to predicate devices for the treatment of inflammatory acne. However, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The document primarily serves as a regulatory submission for market clearance based on substantial equivalence, rather than a detailed report of a performance study with specific acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because the necessary information is not present in the provided text.

    Specifically, the document states: "The differences in the specifications of the EsteLux LuxVIM and the ClearTouch do not result in different performance or raise new questions of safety or efficacy. In addition, clinical data was provided to support the safety and efficacy of the LuxV handpiece." This indicates that clinical data was provided, but the details of that data, including the points you've requested, are not included in this 510(k) summary.

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