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510(k) Data Aggregation
K Number
K241707Device Name
OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL
Manufacturer
Unicon Optical Co., Ltd.
Date Cleared
2024-07-12
(29 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Unicon Optical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Device Description
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).
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K Number
K213216Device Name
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Manufacturer
Unicon Optical Co., Ltd
Date Cleared
2022-01-18
(111 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Unicon Optical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Device Description
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280mm -315nm), and >70% in the UVA range (316nm - 380nm).
The Oualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in a spherical design configuration.
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K Number
K191929Device Name
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Manufacturer
UNICON Optical CO., LTD
Date Cleared
2019-09-17
(60 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
UNICON Optical CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Device Description
Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as aspherical lenses manufactured by cast-molding method. The material is a high water content (59 % wt/wt) material. The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny] ethyl methacrylate} which is included during the manufacturing process as an additive to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm.
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K Number
K182734Device Name
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
Manufacturer
UNICON Optical CO., LTD
Date Cleared
2019-05-16
(230 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
UNICON Optical CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
Device Description
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.
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K Number
K141917Device Name
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
Manufacturer
UNICON OPTICAL CO., LTD.
Date Cleared
2014-10-17
(94 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
UNICON OPTICAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Device Description
UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.
With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.
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