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510(k) Data Aggregation

    K Number
    K003161
    Device Name
    ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
    Manufacturer
    LES LABORATOIRES BLANCHARD
    Date Cleared
    2000-12-15

    (66 days)

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

    LES LABORATOIRES BLANCHARD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982904
    Device Name
    ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    LES LABORATOIRES BLANCHARD
    Date Cleared
    1998-09-01

    (14 days)

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

    LES LABORATOIRES BLANCHARD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in not-aphakic persons with non-diseased eyes. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either heat (thermal) or chemical (not heat) disinfection systems.
    Device Description
    The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is available as a lens with an aspheric front surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The lens is constructed to provide optimum edge thickness and contour, with the central area providing the reading power in the equivalent of a 2.00 diopter near addition. The aspheric front curve undergoes a progressive power change, resulting in intermediate and distance power outward from the center. The lens is a flexible transparent shell of the following dimensions: Chord diameter: Baber: steps) The lens material, hioxifilcon B, is a hydrophilic co-polymer of glycerol methacrylate (GMA) and 2-hydroxyethyl methacrylate (2-Hema), crosslinked with ethylene glycol dimethacrylate. The lens is swollen to equilibrium state in sterile buffered saline solution, and contains 48% water by weight when fully
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