LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021977
    Device Name
    HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
    Manufacturer
    CONTAMAC LTD.
    Date Cleared
    2002-09-12

    (87 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K032256
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Contamac Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and low level corneal toricity up to 2.00D) in aphakic or not-aphakic persons with nondiseased eyes. The lens may be disinfected using chemical disinfection only.

    The Contamac Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism where a spherical lens does not neutralize any residual over-refraction) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for a contact lens. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

    Therefore, none of the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for training set) can be extracted from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1