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510(k) Data Aggregation

    K Number
    K954124
    Device Name
    O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    OPTICAL POLYMER RESEARCH, INC.
    Date Cleared
    1996-03-19

    (200 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity.

    RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.

    Device Description

    O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye act as a refracting medium to focus light rays on the retina.

    AI/ML Overview

    Here's an analysis of the provided text regarding the O->PERM 30A (sterafocon A) contact lens, structured to address your specific questions.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Metric (Criteria)Reported Device Performance
    SafetyAdverse Reactions (none reported)"There were no lens related Adverse Reactions reported in the study."
    Slit Lamp Findings (typical, no treatment required)"All Slit Lamp Findings were typical... No slit lamp findings required treatment."
    Bioburden Level (
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