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510(k) Data Aggregation
K Number
K970312Device Name
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
Manufacturer
FLEXLENS, INC.
Date Cleared
1997-04-02
(65 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
FLEXLENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961943Device Name
FLEXLENS
Manufacturer
FLEXLENS, INC.
Date Cleared
1996-10-01
(134 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
FLEXLENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FLEXIENS (hefilcon A) HARRISON Post Refractive Surgery Contact Tens is indicated for Daily Wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
Device Description
The FLEXI.ENS (hefilcon A) Harrison Post Refractive Surgery Contact Lens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric base curve and a spherical front surface. The lens is lathe cut from hefilcon A, a hydrophilic random copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone crosslinked with ethylene glycol dimethacrylate. It consists of 55% hefilcon A and 45% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
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K Number
K962000Device Name
FLEXLENS(METHAFILCON A)
Manufacturer
FLEXLENS, INC.
Date Cleared
1996-10-01
(132 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
FLEXLENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FLEXI.ENS 55 (methafilcon A) HARRISON Post Refractive Surgery Contact Tens is indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
Device Description
The FIFXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric hase curve and a spherical front surface. The lens is lathe cut from methafilcon A. a random copolymer of 2-hydroxyethy) methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. It consists of 45% methafilcon A and 55% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The physical properties of the lens are as follows:
Refractive Index: 1.4153
Light Transmittance: greater than 95%T
Water Content: 55%
Oxygen Permeability: Dk=18 X 10-11 at 35 °C (measured by the standard Fatt method)
Specific Gravity: 1.090 g/cc
The FT.FXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear was developed to improve the visual acuity of those patients who require improved vision after photorefractive keratectomy, radial keratotomy, and other corneal refractive procedures. Other factors taken into consideration were the following:
1. The topographical profile is such that it is difficult to achieve a satisfactory posterior lems surface to cornea alignment with rigid gas permeable contact l enses .
2. Conventional soft (hydrophilic) contact lens designs do not readily align with the visual axis of the PRS or RK eye or supply sufficient masking of the corneal astigmatism.
3. Conventional toric soft (hydrophilic) contact lenses are limited in their ability to provide a stable level of visual acuity on cases of extreme central flattening in conjunction with irregular astigmatism.
The Harrison Post Refractive Surgery Lens differs from the standard spherical FLEXIENS Custom Sphere in that it incorporates a flat central optical zone with a thickness which varies with power (-1.00n will be approximately 0.30mm thick at the center). The size of the optical zone is generally 8.0mm. The peripheral carrier is thinner than most standard soft (hydrophilic) contact lenses, approximately 0.08mm to 0.10mm, to ensure limbal draping which will exhibit the characteristics (on the eye) of a peripheral aspheric design. In some cases the periphery is manufactured with a steeper curvature than the base curve.
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K Number
K950294Device Name
FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
Manufacturer
FLEXLENS, INC.
Date Cleared
1996-04-11
(442 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
FLEXLENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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