Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K973847
    Device Name
    AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
    Manufacturer
    MARTIN DALSING
    Date Cleared
    1997-12-08

    (61 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARTIN DALSING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.
    Device Description
    The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 36% water by weight.
    Ask a Question
    K Number
    K973597
    Device Name
    AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
    Manufacturer
    MARTIN DALSING
    Date Cleared
    1997-11-20

    (59 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARTIN DALSING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AL-47 (isofilcon) Soft Contact Lens for daily wear are indicated for the correction of visual acuty in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
    Device Description
    AL-47 (isofilcon) Hydrophilic Daily Wear Contact Lens (clear, lathe-cut, parametric release)
    Ask a Question

    Page 1 of 1