Paragon Vision Sciences, Inc.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

  2023-05-05

  Paragon Vision Sciences, Inc.

GUDID#

• Paraperm O2 - Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Paraperm® O2 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® O2 rigid gas permeable tinted lenses offer a handling aid for locating the lens.

  Paragon Vision Sciences, Inc.

  2018-02-23

• Paragon Z CRT - "Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone"" and a non-curving “Landing Zone”.The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.Paragon Z CRT Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process."

  Paragon Vision Sciences, Inc.

  2021-04-05

• Paragon Z CRT Dual Axis - "Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone"" and a non-curving “Landing Zone”.The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.Paragon Z CRT Dual Axis Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process."

  Paragon Vision Sciences, Inc.

  2021-04-05

• Paraperm EW - Paraperm® EW (pasifocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. Paraperm® EW rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The Paraperm® EW rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate.The Paraperm® EW rigid gas permeable tinted lenses offer a handling aid for locating the lens.

  Paragon Vision Sciences, Inc.

  2018-02-23

• FSA 38 - FSA 38 (paflufocon E) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior, posterior or bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FSA 38 (paflufocon E) rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomer.

  Paragon Vision Sciences, Inc.

  2018-03-16

• FSA 52 - FSA 52 (migafocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior, posterior or bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FSA 52 (migafocon A) rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomer.The FSA 52 (migafocon A) rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens.

  Paragon Vision Sciences, Inc.

  2018-03-16

• SportSight GP - SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior, posterior or bitoric surfaces. the posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and cornea.The SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lens material is a thermoset copolymer dervied from fluorosilicone acrylate monomer. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable lenses deliver substantial attenuation of bright light and resultant reduction of glare. SportSight GP lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. All environmental UV radiation (including UVA and UVB) is reduced to less than 1% transmission. Blue light (below 500nm) is reduced to less than 10% in SportSight yellow and SportSight brown or 36% in SportSight gray.

  Paragon Vision Sciences, Inc.

  2018-02-23

• HDS HI 1.54 - HDS HI 1.54 (pahrifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior, or bitoric surfaces in clear and tinted versions. the posterior curve is selected as as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power in correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The HDS HI 1.54 rigid gas permeable contact lens material is a thermoset copolymer derived from acrylated, silicone acrylate, and fluorosilicone acrylate monomers, dimers and oligomers. The HDS HI 1.54 rigid gas permeable tinted lenses offer a handling aid for locating the lens and may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-02-02

• Single Lens BillBoard - The 700 Single Lens Billboard Case base is fabricated from a low-density polypropylene plastic resin. The overall length is approximately 2.240 in., width is approximately 1.050 in. and height approximately 0.450 in. It has a single lens well and is paired with the Plain cap.

  Paragon Vision Sciences, Inc.

  2017-12-08

• Bi-Lens BillBoard - The Bi-Lens Billboard Case base is fabricated from a low-density polypropylene plastic resin. The overall length is approximately 2.240 in.; width is approximately 2.250 in. and height approximately 0.450 in. It has two lens wells that are paired with the Left cap marked with an L and a plain cap for the right well.

  Paragon Vision Sciences, Inc.

  2017-12-08

• Optacryl 60 - Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses withspherical anterior and posterior surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve isselected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allowstear exchange between the lens and the cornea.The Optacryl® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate.The lens material is available in blue, green, or gray versions. The blue lens contains Microlith Blue 4 G-K; the green lens containsSunfast Green No. 7; and, the gray lens contains D&C Green No. 6, D&C Violet No. 2, and Perox Yellow No. 9 as the color additives.

  Paragon Vision Sciences, Inc.

  2017-10-24

• Oxfore100 - The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs:• Spherical• Aspherical• Toric• Mulifocal • Scleral • Semi-scleral Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404.These devices will not be marketed with multiple components or any required accessories.

  Paragon Vision Sciences, Inc.

  2023-09-18

• Fluoroperm 92 - FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric,bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm 92 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FluoroPerm® 92 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.FluoroPerm® 92 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Fluoroperm 60 - FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm® 60 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Fluoroperm 30 - FluoroPerm® 30 (paflufocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FluoroPerm® 30 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.FluoroPerm® 30 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Fluoroperm 151 - FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses for daily wear and extended wear are available as lathe cut or molded firm contact lenses with spherical front and back surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The FluoroPerm® 151 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.FluoroPerm® 151 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Paragon HDS - Paragon HDS® (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in tinted versions. Paragon HDS® rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The Paragon HDS® rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.The Paragon HDS® rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Paragon HDS100 - Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses for daily wear and extended wear are available as lathe cut or molded firm contact lenses with spherical front and back surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The Paragon HDS ®100 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.The Paragon HDS ®100 rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Paragon Thin - Paragon Thin™ (paflufocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The Paragon Thin™ rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.The Paragon Thin™ rigid gas permeable tinted lens offers color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2018-03-23

• Paragon CRT - Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, A mathematically designed sigmoidal corneal proximity “Return Zone” and A non-curving “Landing Zone”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2021-04-05

• Paragon CRT100 - Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”.The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2021-04-05

• Paragon CRT Dual Axis - Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon CRT Dual Axis® Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: the central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”.The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.Paragon CRT Dual Axis® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2021-04-05

• Paragon RG-4 - Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea.The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort.Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for corneal reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

  Paragon Vision Sciences, Inc.

  2021-04-05

• Deep Well Lens Case (Smooth - Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a smooth lens well surface. They are used for the storage and chemical disinfection of hard, GP or soft contact lenses. They are not to be used with heat disinfection.

  Paragon Vision Sciences, Inc.

  2017-12-08

• Deep Well Lens Case (Ribbed) - Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a ribbed lens well surface. They are used for the storage and chemical disinfection of hard, GP or soft contact lenses. They are not to be used with heat disinfection.

  Paragon Vision Sciences, Inc.

  2017-12-08

• Vial Assembly - Contact lens vial with cap and gasket/clawThe finished assemblies can be made with variation in the color of the cap and the insertion of a gasket or a claw. Additionally, the claw has three distinct sizes, Small (S), Large (L), and Extra Large (X).

  Paragon Vision Sciences, Inc.

  2017-12-08

• Optacryl 60 - Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses with spherical anterior and

  PARAGON VISION SCIENCES, INC.

  2017-10-24