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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034065 ()
  • 10811059034062 ()


  • Soft corrective contact lens, daily-disposable
1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034058 ()
  • 10811059034055 ()


  • Soft corrective contact lens, daily-disposable
1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034041 ()
  • 10811059034048 ()


  • Soft corrective contact lens, daily-disposable
SynergEyes petrafocon A hem-larafilcon A casted button
SYNERGEYES, INC.
petrafocon A hem-larafilcon A
In Commercial Distribution

  • A50009 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
Synergeyes paflufocon D – hem-iberfilcon A Casted Buttons
SYNERGEYES, INC.
paflufocon D – hem-iberfilcon A
In Commercial Distribution

  • A50006 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
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.
Oxfore100
In Commercial Distribution

  • B22225 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
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.
HDS HI 1.54
In Commercial Distribution

  • B22216 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
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.
SportSight GP
In Commercial Distribution

  • B22215 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
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.
FSA 52
In Commercial Distribution

  • B22214 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
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.
Paragon Thin
In Commercial Distribution

  • B22212 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
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