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510(k) Data Aggregation

    K Number
    K984143

    Validate with FDA (Live)

    Device Name
    FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1999-02-16

    (90 days)

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

    Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)

    Device Description

    Fibra-Sonics Phaco III and IIIP Fragmentation System

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "FIBRA-SONICS PHACO III or IIIP Fragmentation Systems". It states that the device is "substantially equivalent" to predicate devices, but it does not include details on specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications.

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