Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K230824
    Device Name
    IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
    Manufacturer
    Art Optical Contact Lens, Inc.
    Date Cleared
    2023-09-06

    (166 days)

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

    Art Optical Contact Lens, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The IntelliWave3 multifocal (efrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eves that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
    Device Description
    The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to became soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). 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 (efrofilcon A) 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
    Ask a Question
    K Number
    K152046
    Device Name
    Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
    Manufacturer
    ART OPTICAL CONTACT LENS, INC.
    Date Cleared
    2015-11-24

    (124 days)

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

    ART OPTICAL CONTACT LENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters. The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
    Device Description
    The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, 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. The non-ionic lens material, (safrofilcon A) is a daily wear silicone hydrogel contact lens that is characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness.
    Ask a Question
    K Number
    K142641
    Device Name
    Intelliwave4
    Manufacturer
    ART OPTICAL CONTACT LENS, INC.
    Date Cleared
    2015-01-12

    (117 days)

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

    ART OPTICAL CONTACT LENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intelliwave4, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Intelliwave4, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters. The Intelliwave4, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave4, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave4, irregular cornea (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the eye. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
    Device Description
    The Intelliwave4 Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, 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. The non-ionic lens material (safrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). 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 (safrofilcon A) 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution. In the Intelliwave4 Contact Lens with UV Blocker and center thickness of 0.18mm, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2-(4-Benzoyl-3-hydroxyphenoxy)ethyl acrylate. The UV blocking for Intelliwave4 lenses averages > 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380mm. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.
    Ask a Question
    K Number
    K100221
    Device Name
    INTELLIWAVE3
    Manufacturer
    ART OPTICAL CONTACT LENS, INC.
    Date Cleared
    2010-09-14

    (231 days)

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

    ART OPTICAL CONTACT LENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntelliWave3, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The IntelliWave", toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated I he correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The IntelliWave", multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave", multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave', irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
    Device Description
    The IntelliWave3 Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, 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. The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). 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 (efrofilcon A) soft birghilic 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
    Ask a Question
    K Number
    K073621
    Device Name
    INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
    Manufacturer
    ART OPTICAL CONTACT LENS, INC.
    Date Cleared
    2008-07-03

    (190 days)

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

    ART OPTICAL CONTACT LENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters. The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily, wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters. The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave2, Multifocal Toric (Ilioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lons may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The IntelliWave1, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this matcrial allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121. The IntelliWave2, Soft Daily Wear Contact Lenses are fabricated from (Hioxifilcon B), 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. The non-ionic lens material, hioxifilcon B is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
    Ask a Question

    Page 1 of 1