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510(k) Data Aggregation

    K Number
    K213554
    Device Name
    Sentient Manufacturing Laser Fiber
    Date Cleared
    2022-02-02

    (86 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sentient Manufacturing LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sentient Manufacturing Laser Fiber System is intended to deliver the laser radiation to the target tissue when used with any cleared certified surgical laser with operational wavelength between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
    Device Description
    The Sentient Manufacturing Laser Fiber System is a fiber optic delivery device, with the intended use of delivering laser radiation to soft tissue via contact and non-contact procedures, with any compatible laser system. The Sentient Manufacturing Laser Fibers consist of a fiber optic core, cladding, coating, laser specific compatible connector (proximal end), and optional tip configurations on the distal end (sometimes left bare). The device length can vary from 3 - 5 meters in length with core diameter sizes of 200, 400, 605, 800 and 1000 microns. The device also includes a fiber stripper, fiber cleaver, canula and hand piece to prepare and use the fibers in specific procedures. The proximal end of the fiber optic is connected to the laser system via SMA-905 or compatible connector type. This connection between the fiber and the laser system allows for the laser radiation to transmit through the fiber core and output at the distal end of the fiber optic. The fiber connector also keeps the laser centered on the fiber optic surface to ensure proper power transmission throughout the fiber optic. The fiber optic itself is multilayer; comprised of a core, cladding, and a coating. The fiber cladding and coating provide a protective laver around the core. They also have a low refractive index to keep the power confined inside of the fiber core. The distal end of the laser fiber can have multiple configurations to fit the needs of the treatment application. The most common configuration of the distal end is primarily a bare fiber, with a polished surface.
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