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510(k) Data Aggregation

    K Number
    K971515
    Device Name
    PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)
    Manufacturer
    BIOMED DEVICES CORP.
    Date Cleared
    1997-05-20

    (25 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PROMED 38 SOFBLU (Toric) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and refractive astigmatism not exceeding 10 Diopters.

    The PROMED 38 SOFBLU (Spherical) (polymacon) 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. The lens may be worn by persons who exhibit reffactive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a contact lens. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested information based on the provided text.

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