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510(k) Data Aggregation

    K Number
    K222236
    Device Name
    miCOR System Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2022-08-24

    (29 days)

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

    The intended use of the miCOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the miCOR System Lens Fragmentation System. This document, while indicating the device's clearance for market and its intended use, does not contain any information regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information in the table or the subsequent numbered points based solely on the text provided. The document focuses on regulatory compliance and the determination of substantial equivalence, not on the detailed technical study results.

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