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510(k) Data Aggregation

    K Number
    K960926
    Device Name
    POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
    Manufacturer
    UNILENS CORP., USA
    Date Cleared
    1996-04-10

    (35 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K941836
    Why did this record match?
    Device Name :

    POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS

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

    Not Found

    Device Description

    The Power Plus (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design the same as many other lenses on the market, such as the Unilens 38 (polymacon) Aspheric Contact Lens (510(k) K941836), Ideal Optics PS (polymacon) Aspheric Contact Lens (PMA No. P830012-S003), the Fulfocus (polymacon) Aspheric Contact Lens manufactured by Contact Lens Corporation of America (PMA No. P830006-S005), the Allvue (polymacon) Aspheric Contact Lens manufactured by Salvatori Ophthalmics (PMA No. P840006-S007) and the VX Soft Lens (polymacon) Aspheric Contact Lens manufactured by GBF Contact Lens (PMA No. P780013-S004 approved August 13, 1991).

    The Power Plus (polymacon) Aspheric Contact Lens is a front surface asphere consisting of multiple aspheric zones with a spherical base. The most plus power is in the center of the lens. with the power becoming more minus towards the periphery. This is a similar design as the other aspheric lenses listed above and the Unilens (hefilcon A) Soft (Hydrophilic) Aspheric Contact Lens which has been manufactured at this facility since our approval June 6, 1990 under PMA No. P850002-S005. The lenses have been designed so as to allow about 1 mm movement on the blink. This movement of the lens provides tear exchange to increase the oxygen under the lens and will assist in the removal of corneal metabolic wastes.

    AI/ML Overview

    This document is a 510(k) summary for a contact lens, which is a premarket notification to the FDA for medical devices. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

    The document discusses:

    • The material of the contact lens (polymacon) and its history of use.
    • The manufacturing process.
    • The aspheric design of the lens and its similarities to other approved lenses.
    • The safety rationale based on the use of a known polymer and accepted design.
    • The manufacturer's experience.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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