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510(k) Data Aggregation

    K Number
    K073591
    Device Name
    MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    2008-03-13

    (84 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K090161
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the MicroSTAAR™ MSI Injector Foam Tip System, a device intended to fold and insert intraocular lenses.

    The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot fulfill your request for the detailed table and study information. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls provisions. It does not include performance data, study design, or ground truth establishment relevant to the questions asked.

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