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510(k) Data Aggregation
K Number
K152657Device Name
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
Manufacturer
Date Cleared
2016-05-17
(244 days)
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
SMART PERFORMER CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
Device Description
The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available visibility tinted and cosmetic tinted. The visibility tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone, with iron oxides (red) or C.I. Pigment green 7. The cosmetically tinted lens is available in GREEN and RED. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
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K Number
K151847Device Name
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
Manufacturer
Date Cleared
2016-03-04
(241 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
SMART PERFORMER CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00 D of astigmatism or less. The lenses are available with a visibility-handling tunt or with a decorative tint intended to enhance or alter the apparent color of the eve.
Eyecare practitioners may prescribe the contact lens for frequent wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Device Description
The SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 38% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization.
The SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone. The lens is colored with one or more of the following "list" color additives: iron oxides (red), titanium dioxide, C.I. Pigment green 7, C.I. Reactive blue 19, D&C Yellow 10 and Phthalocyaninato(2-) copper. The lens is available in the following colors: BLACK, BLUE, GRAY, GREEN, BROWN, PINK, and VIOLET. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
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