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510(k) Data Aggregation

    K Number
    K252052

    Validate with FDA (Live)

    Date Cleared
    2026-03-25

    (267 days)

    Product Code
    Regulation Number
    886.4670
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations.

    The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

    The Bausch + Lomb Anterior Vitrectomy Cutter Packs are intended for use with a Bausch + Lomb Microsurgical System for vitrectomy during anterior segment surgery. The Posterior Vitrectomy Cutter Packs are intended for use with a Bausch + Lomb Microsurgical System for vitrectomy during posterior segment surgery. The Combined Vitrectomy Cutter Packs are intended for use with a Bausch + Lomb Microsurgical System for both vitrectomy during posterior segment surgery and for phacoemulsification of an opacified crystalline lens during anterior segment surgery.

    Device Description

    The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation, vitreous aspirating, cutting, and endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a laser module intended for retinal photocoagulation and laser trabeculoplasty.

    A selection of disposable single-use procedure packs is available for use with the system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to and from the patient as well as a selection of components (cannulas, cutters, probes, drapes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility.

    The Bi-Blade™+ vitrectomy cutters are powered by a pneumatic pulse that operates the guillotine style cutter. The cutter has dual side ports and an aspiration channel that allows for aspiration during surgery. Each Bi-Blade™+ vitrectomy cutter is packaged and sterilized by gamma radiation.

    AI/ML Overview

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