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510(k) Data Aggregation

    K Number
    K990725
    Device Name
    NUVOLASE 532 LASER SYSTEM
    Manufacturer
    AMERICAN LASER CORP.
    Date Cleared
    1999-03-22

    (17 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K972561
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nuvolase 532 Laser System for Ophthalmology is intended for use in retinal and macular photocoagulation and trabeculoplasty.

    Device Description

    The Nuvolase 532 Laser System for Ophthalmology is a continuous-wave frequency-doubled diode-pumped Nd:YAG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. Depending on the delivery device efficiency, the maximum power level may be as much as 2.0 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and laser slit lamp.

    AI/ML Overview

    I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for the Nuvolase 532 Laser System for Ophthalmology, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and confirms that its modifications do not affect its indications for use, materials, method of manufacture, or technology.

    Therefore, I cannot provide the requested table and information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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