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510(k) Data Aggregation

    K Number
    K091327
    Device Name
    ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
    Manufacturer
    ALDEN OPTICAL LABS., INC.
    Date Cleared
    2010-06-25

    (416 days)

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

    ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT

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

    The Alden HP 54 Spherical soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters. The Alden HP 54 Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and presbyopia, with add powers not exceeding 4.00 diopters. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not . interfere with visual acuity. The Alden HP 54 Toric Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters, and presbyopia with add powers not exceeding 4.00 diopters. The lenses are available for either conventional wear or planned replacement modalities.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for contact lenses. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary.

    The document primarily focuses on:

    • Substantial Equivalence: Stating that the Alden HP 54 contact lenses are substantially equivalent to legally marketed predicate devices.
    • Regulatory Information: Details regarding the device's classification, applicable regulations, and responsibilities of the manufacturer.
    • Indications for Use: Describing what the lenses are intended to correct (e.g., myopia, hyperopia, astigmatism, presbyopia) and in what patient populations (aphakic/not aphakic, non-diseased eyes).

    Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this document. This kind of information is typically found in the clinical data section of a 510(k) submission, which is not included in this clearance letter.

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