Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K983836
    Device Name
    RIGID GAS PERMEABLE CONTACT LENS SOLUTION
    Manufacturer
    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
    Date Cleared
    1999-02-11

    (104 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Boston® Enhanced Original Formula Conditioning Solution is indicated for use in wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
    Device Description
    The modified Boston® Enhanced Original Formula Conditioning Solution is a sterile conditioning solution used in the care of rigid gas permeable contact lenses and is indicated for the wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate contact lenses. This product is a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
    Ask a Question
    K Number
    K980741
    Device Name
    BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
    Manufacturer
    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
    Date Cleared
    1998-05-11

    (74 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BOSTON EO (enflufocon B) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
    Device Description
    The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).
    Ask a Question
    K Number
    K962512
    Device Name
    BOSTON CONTACT LENS CASE
    Manufacturer
    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
    Date Cleared
    1996-07-12

    (15 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.
    Device Description
    The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interiors of the wells and caps contain elevated ridges to prevent the adherence of rigid gas permeable contact lenses to the surfaces.
    Ask a Question

    Page 1 of 1