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510(k) Data Aggregation

    K Number
    K964696
    Device Name
    SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
    Manufacturer
    SUNSOFT CORP.
    Date Cleared
    1997-02-20

    (90 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 Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline. It is indicated for the correction of visual acuity.

    Device Description

    The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline.

    AI/ML Overview

    This document is a 510(K) summary for a contact lens and does not contain the information required to populate the fields of "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance. This document describes the biocompatibility, physical/optical characteristics, and manufacturing process validation of a contact lens, comparing a new manufacturing method to an existing one. It is not about the performance of a device that uses an algorithm or AI.

    Therefore, I cannot provide the requested information from the given text.

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