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510(k) Data Aggregation

    K Number
    K041011
    Date Cleared
    2004-12-14

    (238 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ULTRALIGHT II ND:YAG LASER SYSTEM

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

    At the 1064 nm wavelength dark ink tattoo removal of pigmented lesions . and the removal or lightening of hair.
    and the Femoval of ifgifteding of help of red ink tattoos, treatment of vascular hesions . including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

    Device Description

    The UltraLight II Nd:YAG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the bandpiece. In standard use, the handpiece is held against the treatment area dn)the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.

    AI/ML Overview

    The provided text does NOT contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the UltraLight II Nd:YAG Laser System, indicating its equivalence to predicate devices and outlining its intended uses.

    Specifically, the "Performance Data: Results of Clinical Study:" section explicitly states "None," meaning no clinical study was presented in this summary to demonstrate performance or meet acceptance criteria.

    Therefore, I cannot populate the requested table and information as the necessary data is not present in the provided text.

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