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510(k) Data Aggregation

    K Number
    K160677
    Device Name
    MICRORUPTOR 6
    Manufacturer
    MERIDIAN AG
    Date Cleared
    2017-05-19

    (435 days)

    Product Code
    GEX,LXS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICRORUPTOR 6

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

    The Microruptor 6 Nd: Y AG Laser is indicated for:

    • posterior capsulotomy,

    • pupillary membranectomy

    • peripheral iridotomy

    Device Description

    Microruptor 6 Nd: YAG Laser

    AI/ML Overview

    I am sorry but this document does not contain the information you are requesting. The document is an FDA 510(k) clearance letter for the Microruptor 6 Nd: YAG Laser, which indicates the device has been found substantially equivalent to a predicate device. It specifies the indications for use but does not include details on acceptance criteria and a study proving the device meets those criteria, or any information about AI algorithms.

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