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510(k) Data Aggregation

    K Number
    K250501

    Validate with FDA (Live)

    Device Name
    System Sophi
    Manufacturer
    Date Cleared
    2025-11-14

    (267 days)

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

    The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for liquid irrigation and aspiration, lens fragmentation and ultrasonic phacoemulsification, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).

    Device Description

    The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for lens fragmentation and ultrasonic phacoemulsification, liquid irrigation and aspiration, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).

    A cassette is the interface between the System Sophi device and the surgical handpiece. It is used to regulate the balanced saline solution (BSS) irrigating fluid to the handpiece, to aspirate lens fragments and liquids from the handpiece, to monitor irrigation and aspiration flow and pressure and deposition of lens fragments and fluid into the waste bag for disposal. The cassette ports and tube connectors are coded to ensure proper connections at any time.

    The system is controlled with a foot pedal (surgeon) and a graphical user interface (assistant). System Sophi is powered by mains voltage (AC-powered) or through a battery.

    Only company-validated and recommended disposable sterile equipment and designated instruments and hand pieces are allowed.

    The Sophi system is offered in three configurations: Sophi Premium, Sophi Eco and Sophi A, differing in the included options and accessories.

    AI/ML Overview

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