LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251876
    Device Name
    cleadew GP hydra one
    Manufacturer
    Ophtecs Corporation
    Date Cleared
    2025-10-09

    (113 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K181627
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    cleadew GP hydra one is indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

    Device Description

    Ophtecs cleadew GP hydra one is a sterile, aqueous, buffered solution that contains Boric acid, Disodium Phosphate, Trometamol, Glutamic Acid, Sodium Chloride, Polyoxyethylene 9 Lauryl Ether, Tetrasodium (1-hydroxy-1,1-ethanediyl)bis(phosphonate), C12-13 Alkyl Glyceryl Hydrolyzed Hyaluronate, Sodium Hyaluronate and Hypromellose; preserved with Hydrogen peroxide (0.004%) and Polyhexamethylene biguanide hydrochloride (0.0005%). The solution is for cleaning, removing protein, rinsing, disinfecting, conditioning, and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1