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510(k) Data Aggregation
K Number
K133079Device Name
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
2013-12-17
(78 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iO2 Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with nondiseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.
The ASTERA Multifocal iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or nonaphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.
The iO2Toric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non- aphakic persons with non diseased eyes in a spherical power range of +30.00 to -30.00 D and a cylinder power range up to -10.0D.
The ASTERA Multifocal Toric iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non- aphakic patients with non-diseased eyes in a spherical power range of +30.00 to -30.00 D, a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.
iO2 lenses may be disinfected using chemical (not heat) disinfecting systems.
Device Description
The iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, multifocal, toric, and toric-multifocal designs. Specifically, the iO2 Sphere, iO2 Toric, ASTERA Multifocal iO2, and ASTERA Multifocal Toric iO2 models are hemispheric flexible shells. All iO2 lenses are plasma treated in the dry state prior to initial hydration. The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.
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K Number
K102557Device Name
NOVAKONE SPHERICAL AND TORIC LENSES
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
2011-04-26
(231 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise non-diseased eyes. 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 NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) and astigmatism in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.
The lenses may be prescribed for either conventional wear or planned replacement modalities, and may be disinfected with a chemical or heat disinfection system.
Device Description
Not Found
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K Number
K091327Device Name
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
2010-06-25
(416 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alden HP 54 Spherical soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (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 Alden HP 54 Toric soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters. The Alden HP 54 Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and presbyopia, with add powers not exceeding 4.00 diopters. 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 Alden HP 54 Toric Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters, and presbyopia with add powers not exceeding 4.00 diopters. The lenses are available for either conventional wear or planned replacement modalities.
Device Description
Not Found
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K Number
K052703Device Name
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
2005-11-10
(43 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alden Classic (polymacon), Alden Classic 55 (methafilcon A), Alden HP 49 (hioxifilcon B) and Alden HP 59G (hioxifilcon A) Multifocal (Spherical and 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 refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. The lenses are available for either conventional or planned replacement modalities.
Device Description
Alden Classic (polymacon) Multifocal Contact Lens (Spherical and Toric designs); Alden Classic 55 (methafilcon A) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 49 (hioxifilcon B) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 59G (hioxifilcon A) Multifocal Contact Lens (Spherical and Toric designs).
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K Number
K042242Device Name
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
2004-09-15
(27 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere and 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 possess refractive astigmatism not exceeding 10 Diopters. They are available for either conventional wear or planned replacement modalities.
Device Description
Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses
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K Number
K983278Device Name
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
1998-11-25
(69 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens 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 prostheric contact leases for cosmetic management of conditions such as comeal, ins 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 may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) 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 lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifileon B) Toric Soft Contact Leases 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 not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.
The leases are available within a planned replacement program with frequency of replacement determined by the practitioner.
Device Description
The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Contact Lens is 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. A tint mixture containing; Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17 -Dimethoxydinaphtho [1.2.3 -cd:3'.2'.1' -lm] pervlene-5,10-dione, and Brown 16,23 -Dihydrodinaphtho [2,3-a.2 ] 3 ' -i] napth [2',3' ; 6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.
The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
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 Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
The OXYLENS TINTED may contain a single listed color additive, or may contain a combination of color additives in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The color additives are added to the contact lens for enhancing and/or altering the apparent color of the eve.
In the hydrated state, the OXYLENS TINTED, PROSTHETIC lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a color altering optical surface. The (hioxifilcon B) 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 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
K983053Device Name
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
1998-10-21
(50 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lenses 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 may be disinfected with either a chemical or a heat disinfection system.
Device Description
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas is fabricated from polymacon, 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. A tunt mixture containing: Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17-Dimethoxydinaphtho [1,2,3 -> 1' - Im] perylene-5,10-dione, and Brown 16,23 -Dibydrodinaphtho [2,3-a:2',3' -i] napth [2',3';.6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.
The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or leas 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 occhisive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Tim 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 Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
In the hydrated state, the leas conforms to the curvature of the eye covering the cornes and extending sightly beyond the limbus forming a color altering optical surface. The (polymacon) soft hydrophilic contact leas 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 leas 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
K981252Device Name
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
1998-06-23
(78 days)
Product Code
LPL, OXY
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OXYLENS (hioxifilcon B) 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 byperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters of less where the astigmatism does not interfere with visual acuity.
The OXYLENS (hioxifileon B) 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 not exceeding 10 Diopters.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
Device Description
The OXYLENS (bioxifilcon B) Soft (Spherical & Toric) 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.
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 (hioxifilcon B) 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 eve. 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 48% water by weight.
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K Number
K980554Device Name
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
1998-04-07
(53 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALDEN CLASSIC TINTED (polymacon) 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 ALDEN CLASSIC TINTED (polymacon) 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 not exceeding 10 Diopters.
Device Description
The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, 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. A Blue tint (transparent/enhancing), 7,16-Dichloro-6, 15-dihydro-5, and 9,14,18anthrazinetetrone is added to the lens.
In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) 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 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 38% water by weight.
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K Number
K973967Device Name
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)
Manufacturer
ALDEN OPTICAL LABS., INC.
Date Cleared
1997-12-08
(52 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ALDEN OPTICAL LABS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALDEN CLASSIC (polymacon) 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 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 ALDEN CLASSIC (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual aculty in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.
Device Description
The ALDEN CLASSIC (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, 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 (polymacon) 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 eve. 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 38% water by weight.
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