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510(k) Data Aggregation

    K Number
    K122213
    Device Name
    ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    SOFLEX LIMITED
    Date Cleared
    2012-12-12

    (140 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

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

    The Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons.

    Device Description

    Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about acceptance criteria or performance studies as typically requested for AI/ML device evaluations. Therefore, I cannot provide the requested information based on the given text.

    The document states that the FDA reviewed a premarket notification for the "Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear" and determined it to be substantially equivalent to legally marketed predicate devices. It lists the indications for use as the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons for daily wear.

    However, none of the specific details about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for AI/ML performance testing are present in this regulatory clearance letter.

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