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510(k) Data Aggregation
K Number
K020608Device Name
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
Manufacturer
POLY VUE TECHNOLGIES, INC.
Date Cleared
2002-05-16
(80 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
POLY VUE TECHNOLGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD (polymacon) Aspheric 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 early presbyopia up to 1.25 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with disposal as recommended by the eyecare practitioner. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Device Description
The HD/HDT, (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives.
Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a 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 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. The physical properties of the lens are:
1.445 (hydrated) Refractive Index greater than 90% Light Transmission (clear) Light Transmission (tinted) greater than 90%
Water Content 38 % ± 2% Oxygen Permeability 8.4 X 10-1 (cm /sec) (ml O /ml x mm Hg @ 35 C), (revised Fatt method).
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K Number
K013220Device Name
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
Manufacturer
POLY VUE TECHNOLGIES, INC.
Date Cleared
2001-11-20
(55 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
POLY VUE TECHNOLGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD (polymacon) Aspheric 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 lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The PV (polymacon) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyonic. 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 is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Device Description
The HD/HDT, PV/PVT (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-I his consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique timing pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color subsequently processed to morporate and noloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives.
Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface. The (polymacon) soft hydrophilic sugary ocyone the minous coming a ace. 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 mannualios in a rany arguited warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
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