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    K Number
    K980741
    Device Name
    BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
    Manufacturer
    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
    Date Cleared
    1998-05-11

    (74 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K943177
    Why did this record match?
    Device Name :

    BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)

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

    BOSTON EO (enflufocon B) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

    Device Description

    The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaTest Lens (BOSTON EO) PerformanceControl Lens (BOSTON ES) Performance
    Safety:
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