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510(k) Data Aggregation
K Number
K191397Device Name
OxySoft (olifilcon C) silicone hydrogel soft contact lens
Manufacturer
Visco Vision Inc.
Date Cleared
2019-10-02
(131 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Visco Vision Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OxySoft (olifilcon C) Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The OxySoft (olifileon C) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The OxySoft (olifilcon C) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with nondiseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
Device Description
The OxySoft (olifilcon C) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 46% olifilcon C and 54 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.9% (< 5%) in the UVB range of 280-315nm and 14.7% (< 50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.
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K Number
K180322Device Name
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
Manufacturer
Visco Vision Inc.
Date Cleared
2018-04-20
(74 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Visco Vision Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
Device Description
The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (< 5%) in the UVB range of 280-315nm and 8.7% ( < 50%) in the UVA range of 316-380nm. All colored additives used including ultraviolet absorbing additive (benzophenone based) are listed in 21CFR 73 subpart Dand 74 sbupart D.
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K Number
K141348Device Name
VISCO SOFT CONTACT LENS
Manufacturer
VISCO VISION INC.
Date Cleared
2015-06-22
(396 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
VISCO VISION INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Device Description
The VISCO Soft Contact Lens is a spherical lens with UV blocker. The VISCO Soft Contact Lens is available in hemispherical shell. The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (1.1%) in the UVB range of 280-315nm and less than 50% (9.4%) in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.
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