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510(k) Data Aggregation

    K Number
    K191024
    Device Name
    xPORT Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2019-08-13

    (117 days)

    Product Code
    HQC,MLZ
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    xPORT Lens Fragmentation System

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

    The intended use of the xPORT System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the xPORT Lens Fragmentation System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices for the fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.

    However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    This letter is a regulatory clearance document, not a clinical study report. To fulfill the request, information from the actual 510(k) submission (which is typically much more extensive than just the clearance letter) would be required. Without that underlying data, it's impossible to describe the acceptance criteria and the study proving the device meets them.

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