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510(k) Data Aggregation
K Number
K041700Device Name
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
Manufacturer
CANTOR & NISSEL LTD.
Date Cleared
2004-07-30
(38 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& NISSEL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.
Device Description
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be hand painted in an iris or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of lenses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.
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K Number
K022373Device Name
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
Manufacturer
CANTOR & NISSEL LTD.
Date Cleared
2002-10-07
(77 days)
Product Code
NJH, HQG, NAI
Regulation Number
886.5844Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& NISSEL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.
Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.
Device Description
The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacles that have been precision coated with varying hue and saturation filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. ChromaGen v30 Reading Aid & Color Discrimination Enhancement are available in varying hues and saturation levels duplicate of that available in the ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Soft Contact Lenses. The ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lens has been designed for binocular use, and when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading.
The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.
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K Number
K012132Device Name
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
Manufacturer
CANTOR & NISSEL LTD.
Date Cleared
2002-05-09
(304 days)
Product Code
NIC
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& NISSEL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ChromaGen v3.0 Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.
Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
Device Description
The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are a range of soft lenses with precision tinted I ho on onlying hue and saturation which, when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the encoufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.
The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used in and paragraph with (pation are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
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K Number
K994320Device Name
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
Manufacturer
CANTOR & SILVER LTD.
Date Cleared
2000-10-20
(303 days)
Product Code
NCZ
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& SILVER LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
Device Description
The ChromaGen v2.0 Color Discrimination Enhancement filters are designed specifically to improve discrimination between colors that are normally confused by people with protan or deutan (red-green) color vision deficiencies. The ChromaGen v20 Color Discrimination Enhancement Soft Contact Lenses are a range of soft contact lenses with precision tinted pupils of varying hue and saturation which, when used monocular and binocularly, have been shown to be of use in patients with defective color vision. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This device in not a cure for color vision deficiencies or colorblindness. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted to the eyecare professional instructions. The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethy) methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
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K Number
K992500Device Name
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
Manufacturer
CANTOR & SILVER LTD.
Date Cleared
1999-08-18
(23 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& SILVER LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
Device Description
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted to the eyecare professional instructions.
The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 19, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
Tint Patterns Available:
1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
4. Tinted lens with Black Pupil. Uses the CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
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K Number
K990757Device Name
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA
Manufacturer
CANTOR & SILVER LTD.
Date Cleared
1999-04-21
(44 days)
Product Code
LPL, TRA
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& SILVER LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CANTOR & SILVER SX Tinted (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia. The leases may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-disessed eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
Device Description
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact lens are fabricated from hioxifilcon 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 color enhanced soft contact lenses are tinted with "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The finted contact lenses are available in a light, medium or dark shade of the following enhance colors; Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet, and Amber.
The color additive (timing) effect is formed by reacting one or more of the "listed" additives with HEMA based (poly hydroxyethy) methacrylate) soft contact lens. The color additives used are not removed by lens handling and cleaning/disinfecting procedures as recommended. Except for affecting the amount of light transmitted through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
In the bydrated state, the lens conforms to the curvature of the eye covering the comea and extending slightly beyond the limbus forming a transparent optical surface. The (hioxifilcon A) soft hydrophilic contact lens 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.
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K Number
K981779Device Name
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT
Manufacturer
CANTOR & SILVER LTD.
Date Cleared
1998-06-24
(35 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
**CANTOR **& SILVER LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CANTOR & SILVER 5X (hioxifilcon A) Spherical 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 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
The CANTOR & SILVER 5X (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10 Diopters.
Device Description
The CANTOR & SILVER 5X (hioxifileon A) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon A, which in the dry (unhydrated) state may be machined. 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 (hioxifileon 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.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:
Refractive Index: 1.515 (dry) 1.404 (hydrated)
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Color Pigment Name: Phthalocyanato (2) - (copper)
Water Content: 58% ± 2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 20 X 10 to the power of -11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method)
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