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510(k) Data Aggregation

    K Number
    K971647
    Device Name
    LL BI-FOCAL, DAILY WEAR CONTACT LENS
    Manufacturer
    LOMBART LENSES, LTD.
    Date Cleared
    1997-07-15

    (71 days)

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

    LL BI-FOCAL, DAILY WEAR CONTACT LENS

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

    LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.50 or +3.00.

    Device Description

    LL Bi-Focal , Soft (hydrophilic) Contact lens for Daily Wear

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a contact lens device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges the trade name "LL Bi-Focal, Soft (hydrophilic) Contact lens for Daily Wear" and states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given text.

    To answer your request, I would need a document detailing the specific study conducted for the device's clearance, including acceptance criteria, study design, results, and statistical analysis.

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