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510(k) Data Aggregation

    K Number
    K041086
    Device Name
    PALOMAR STARLUX PULSED LIGHT SYSTEM
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2005-01-13

    (262 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K020839,K040081,K033549,K003886
    Why did this record match?
    Device Name :

    PALOMAR STARLUX PULSED LIGHT SYSTEM

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

    The StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.

    Device Description

    The StarLux Pulsed Light System is a broad spectrum light-based medical device designed for a wide range of clinical applications. The StarLux offers 5 handpieces with Palomar's patented contact cooling technology, each specifically designed for the optimal treatment of specific clinical indications.

    AI/ML Overview

    The provided text is a 510(k) summary for the Palomar StarLux™ Pulsed Light System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for a new, novel function.

    Therefore, many of the requested categories for a study proving device acceptance and performance cannot be directly extracted from this document, as it outlines a regulatory submission process based on equivalence.

    However, I can extract information related to the device's intended use and the general conclusion of the 510(k) submission.

    Here's a summary based on the provided text, indicating where information is not available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit)Reported Device Performance (Implicit)
    Substantial equivalence to predicate devices in terms of safety and efficacy for the stated indications.Performance and results are not explicitly quantified in terms of specific metrics (e.g., clearance rates, reduction percentages). The submission concludes that "The differences in the specifications of the StarLux™ and the predicates do not result in different performance or raise new questions of safety or efficacy."
    Intended Use: Treatment of inflammatory acne.Substantially equivalent to predicate devices for this indication.
    Intended Use: Treatment of cutaneous lesions, including warts, scars, and striae.Substantially equivalent to predicate devices for these indications.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size (Test Set): Not applicable/Not provided. This submission relies on demonstrating equivalence to predicate devices rather than a de novo clinical trial with a test set.
    • Data Provenance: Not applicable/Not provided.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • Not applicable/Not provided. Ground truth in the context of equivalence is not established by expert consensus on a test set, but rather by the regulatory acceptance of the predicate devices.

    4. Adjudication Method for the Test Set

    • Not applicable/Not provided.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

    • No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This type of study is not relevant to a pulsed light system's regulatory submission based on substantial equivalence to existing devices.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

    • Not applicable. This device is a pulsed light system, not an algorithm. Its performance is inherent in its physical operation and effect on tissue, not in an independent algorithmic output.

    7. The Type of Ground Truth Used

    • The "ground truth" for this submission is the established safety and efficacy of the legally marketed predicate devices (Palomar EsteLux (K040081), Palomar StarLux (K033549), Palomar SpaLight (K003886), Lumenis IPL (K020839)) for their respective indications. The StarLux™ is deemed substantially equivalent to these devices.

    8. The Sample Size for the Training Set

    • Not applicable/Not provided. This is not an AI/ML device that requires a training set in the conventional sense.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable/Not provided.

    Summary of the Study (as described in the 510(k) document):

    The "study" presented in this 510(k) submission is a comparison and analysis of the StarLux™ Pulsed Light System against legally marketed predicate devices. The approach is to demonstrate substantial equivalence rather than to conduct a de novo clinical trial with specific performance metrics.

    The conclusion of the submission states: "Based on the foregoing, the StarLux™ pulsed light system is substantially equivalent to the legally marketed claimed predicate devices." This means the device met the regulatory acceptance criteria by showing that its specifications and intended uses are comparable to those of already approved devices, and it does not raise new questions of safety or efficacy.

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