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510(k) Data Aggregation

    K Number
    K150138
    Device Name
    Aspen Laser Systems Therapy Laser System
    Manufacturer
    ASPEN LASER SYSTEMS, LLC
    Date Cleared
    2015-05-08

    (106 days)

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

    Aspen Laser Systems Therapy Laser System

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

    Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, periungual and subungual warts, neuromas, and plantar warts. The VelasII is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for the VELASII Laser System, indicating substantial equivalence to predicate devices. It lists the device's indications for use but does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for a device performance validation.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and classification, not on the technical performance specifics or clinical trial data that would demonstrate acceptance criteria being met.

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