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510(k) Data Aggregation

    K Number
    K013445
    Device Name
    OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
    Manufacturer
    FLORIDA OPTICAL ENGINEERING, INC.
    Date Cleared
    2001-12-26

    (70 days)

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

    FLORIDA OPTICAL ENGINEERING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less.
    Device Description
    OSPREY™ Spherical or Toric (hioxifilcon B) Multifocal Soft Daily Wear Contact Lenses (Clear and Blue Visibility Tint, Lathe-cut from Lens Blanks) are made from clear and a blue visibility tint BENZ-G 3X (hioxifilcon B) lens blanks intended for daily wear for correction of visual acuity of aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses are manufactured by lathe-cutting of lens blanks in dry (i.e. non-hydrated) state into hemispherical shell which can be polished when desired. The toric contact lens have a Toric Base Curve. Osprey™ Multifocal Soft Contact Lens is a center-distance, simultaneous-focus, progressive-addition lens. Focal power within the central power zone is generated on the front surface, beginning at the central distance power, and increasing radially outward. Labeled Add Power is that Add Power which is occurring at the pupillary zone diameter of 3.5 mm. The back surface may be either spherical or toric for correcting astigmatism. The toric lens is held on axis by the superior and inferior front surface flanges, formed by slab-off. The lenses are available in clear and with a blue visibility tint as supplied by the manufacturer of lens blanks.
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