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510(k) Data Aggregation

    K Number
    K983773
    Device Name
    BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1998-12-22

    (57 days)

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

    BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS

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

    The BENZ-G 5X SPHERICAL (hioxifilcon A) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and astigmatism of up to 0.75 Diopters where the astigmatism does not interfere with visual acuty. The lens may be disinfected with either a chemical or a heat disinfection system.

    Device Description

    Benz-G 5X (hioxifilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted, lathe-cut)

    AI/ML Overview

    This document is a 510(k) clearance letter for a contact lens, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the manner requested. The document describes the regulatory approval of a medical device (a contact lens) based on its equivalence to existing products rather than a performance study against specific acceptance criteria.

    Therefore, I cannot provide the requested information from the provided text.

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