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510(k) Data Aggregation

    K Number
    K960811

    Validate with FDA (Live)

    Device Name
    PHACOSCOPE
    Manufacturer
    SAINT JOHN'S PLAZA MEDICAL GROUP
    Date Cleared
    1996-10-02

    (218 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

    Provide illumination at surgical site.

    Device Description

    Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for a medical device (Fiber Optic Phacofragmentation System) and focuses on describing the device, its intended use, and its equivalence to predicate devices, rather than presenting acceptance criteria and study results.

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