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510(k) Data Aggregation

    K Number
    K200056
    Device Name
    Catalys Precision Laser System
    Manufacturer
    AMO Manufacturng USA, LLC
    Date Cleared
    2020-05-18

    (126 days)

    Product Code
    OOE
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMO Manufacturng USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
    Device Description
    Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc-cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).
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