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510(k) Data Aggregation

    K Number
    K024259

    Validate with FDA (Live)

    Device Name
    PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2003-06-20

    (179 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K020839,K020591,K020856,K020453,K013365,K022568
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The New Star Lasers UV-300 Pulsed Light Therapy System is indicated for the treatment of facial, truncal or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos. The UV-300 may be used to treat patients with skin types I-VI.

    Device Description

    The New Star UV-300 Pulsed Light Therapy System is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console unit, which houses the power supply, cooling system, cryogen source, and microcontroller, the handpiece, which contains the light source, and the footswitch.

    AI/ML Overview

    The provided document (K024259) is a 510(k) premarket notification for the New Star Lasers UV-300 Pulsed Light Therapy System. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical performance studies to prove specific acceptance criteria.

    Therefore, the document explicitly states:

    • Nonclinical Performance Data: None.
    • Clinical Performance Data: None.

    Given this, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such studies were not part of this 510(k) submission.

    The "conclusion" in the 510(k) summary is that the device is "substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, and tattoos." This substantial equivalence is based on the device's design, intended use, and technological characteristics being similar to the identified predicate devices, not on new performance data against specific acceptance criteria.

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