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510(k) Data Aggregation

    K Number
    K081178
    Device Name
    OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
    Manufacturer
    CONTAMAC LTD.
    Date Cleared
    2008-10-09

    (167 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

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

    The OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes, The lenses may be disinfected using a chemical disinfection system only.

    Device Description

    OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Daily Wear Contact Lenses.

    AI/ML Overview

    This letter is a medical device approval from the FDA, and as such, it does not contain the detailed technical study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    To provide the information you've requested about acceptance criteria and study details, I would need access to the actual 510(k) summary or the full submission for K081178, which would typically contain performance data and clinical study details if they were required for the specific device type.

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