Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- HJFMagnifier, Hand-Held, Low-Vision1Product Code
- HJGSystem, Reading, Television, Closed-Circuit1Product Code
- HJHLoupe, Binocular, Low Power1Product Code
- HJXReader, Prism, Ophthalmic1Product Code
- HJYReader, Bar, Ophthalmic1Product Code
- HJZCrutch, Ptosis1Product Code
- HKBTelescope, Hand-Held, Low-Vision1Product Code
- HKCSpectacle Microscope, Low-Vision1Product Code
- HKKTelescope, Spectacle, Low-Vision1Product Code
- HOISpectacle, Magnifying1Product Code
- HOTAid, Vision Image Intensification1Product Code
- HPEAid, Vision, Optical, Battery-Powered1Product Code
- HPFAid, Vision, Electronic, Ac-Powered1Product Code
- HPGAid, Vision, Electronic, Battery-Powered1Product Code
- HPIAid, Vision, Optical, Ac-Powered1Product Code
- HQDLens, Contact (Other Material) - Daily2Product Code
- HQGLens, Spectacle, Non-Custom (Prescription)1Product Code
- HQYSunglasses (Non-Prescription Including Photosensitive)1Product Code
- HQZFrame, Spectacle1Product Code
- HRCSterilizer, Soft-Lens, Thermal, Battery-Powered2Product Code
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered2Product Code
- HRLUnit, Beta, Radiation, Ophthalmic2Product Code
- KYEInserter/Remover Contact Lens1Product Code
- LPLLenses, Soft Contact, Daily Wear2Product Code
- K251683Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)2Cleared 510(K)
- K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)2Cleared 510(K)
- K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses2Cleared 510(K)
- K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)2Cleared 510(K)
- K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus2Cleared 510(K)
- K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)2Cleared 510(K)
- K241884HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)2Cleared 510(K)
- K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric2Cleared 510(K)
- K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens2Cleared 510(K)
- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear2Cleared 510(K)
- K240918Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism2Cleared 510(K)
- K242391Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)2Cleared 510(K)
- K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™2Cleared 510(K)
- K240477Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses2Cleared 510(K)
- K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens2Cleared 510(K)
- K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)2Cleared 510(K)
- K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker2Cleared 510(K)
- K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens2Cleared 510(K)
- K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal2Cleared 510(K)
- K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear2Cleared 510(K)
- K230954Samfilcon B Custom Contact Lens2Cleared 510(K)
- K232921DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric2Cleared 510(K)
- K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)2Cleared 510(K)
- K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)2Cleared 510(K)
- K230785Precision1, Precision1 for Astigmatism2Cleared 510(K)
- K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia2Cleared 510(K)
- K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K222500AIR OPTIX COLORS2Cleared 510(K)
- K220143BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear2Cleared 510(K)
- K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)2Cleared 510(K)
- K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens2Cleared 510(K)
- K212806Alcon (serafilcon A) soft contact lenses for daily wear2Cleared 510(K)
- K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)2Cleared 510(K)
- K213164Avaira Vitality2Cleared 510(K)
- K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia2Cleared 510(K)
- K210609AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens2Cleared 510(K)
- K210436Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere2Cleared 510(K)
- K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo2Cleared 510(K)
- K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens2Cleared 510(K)
- K201268Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)2Cleared 510(K)
- K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)2Cleared 510(K)
- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K201013Optixon 1-Day2Cleared 510(K)
- K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens2Cleared 510(K)
- K193399Miru 1day UpSide (midafilcon A)2Cleared 510(K)
- K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism2Cleared 510(K)
- K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC2Cleared 510(K)
- K200243ACUVUE (senofilcon A) Soft Contact Lens Multifocal2Cleared 510(K)
- K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses2Cleared 510(K)
- K191397OxySoft (olifilcon C) silicone hydrogel soft contact lens2Cleared 510(K)
- K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K183670Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens2Cleared 510(K)
- K191121Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens2Cleared 510(K)
- K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac2Cleared 510(K)
- K190965MyDay2Cleared 510(K)
- K181656ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)2Cleared 510(K)
- K190045DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives2Cleared 510(K)
- K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric2Cleared 510(K)
- K182902Precision12Cleared 510(K)
- K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker2Cleared 510(K)
- K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens2Cleared 510(K)
- K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal2Cleared 510(K)
- K182674Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia2Cleared 510(K)
- K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)2Cleared 510(K)
- K181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens2Cleared 510(K)
- K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens2Cleared 510(K)
- K181796FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions2Cleared 510(K)
- K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia2Cleared 510(K)
- K181230Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA2Cleared 510(K)
- K181050Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)2Cleared 510(K)
- K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens2Cleared 510(K)
- K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal2Cleared 510(K)
- K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lens2Cleared 510(K)
- K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal2Cleared 510(K)
- K180299ACUVUE OASYS (senofilcon A) with Photochromic Additive2Cleared 510(K)
- K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens2Cleared 510(K)
- K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens2Cleared 510(K)
- K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens2Cleared 510(K)
- K171447OxyPure Color Silicone Hydrogel Soft Contact Lenses2Cleared 510(K)
- K173086NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K172600AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal2Cleared 510(K)
- K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens2Cleared 510(K)
- K170286Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA2Cleared 510(K)
- K172066DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal2Cleared 510(K)
- K171157PolyDev Soft Contact Lenses2Cleared 510(K)
- K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)2Cleared 510(K)
- K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives2Cleared 510(K)
- K160245Visco (olifilcon A) soft contact lens2Cleared 510(K)
- K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K162596AIR OPTIX COLORS2Cleared 510(K)
- K161931Toricolors (hioxifilcon D) Soft Contact Lenses2Cleared 510(K)
- K161124EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear2Cleared 510(K)
- K161098ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)2Cleared 510(K)
- K160472Hidrocor, Hidrocharme, and Natural Colors2Cleared 510(K)
- K160977PolyDev Soft Contact Lenses2Cleared 510(K)
- K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens2Cleared 510(K)
- K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/20162Cleared 510(K)
- K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric2Cleared 510(K)
- K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear2Cleared 510(K)
- K153305EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear2Cleared 510(K)
- K160212ACUVUE (senofilcon C) Soft Contact Lens2Cleared 510(K)
- K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K151918Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist2Cleared 510(K)
- K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal2Cleared 510(K)
- K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives2Cleared 510(K)
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)2Cleared 510(K)
- K151586Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,2Cleared 510(K)
- K141348VISCO SOFT CONTACT LENS2Cleared 510(K)
- K150385NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses2Cleared 510(K)
- K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear2Cleared 510(K)
- K143280BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens2Cleared 510(K)
- K150293EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)2Cleared 510(K)
- K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear2Cleared 510(K)
- K143431Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)2Cleared 510(K)
- K143632Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K142641Intelliwave42Cleared 510(K)
- K143052Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens2Cleared 510(K)
- K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)2Cleared 510(K)
- K142851CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens2Cleared 510(K)
- K141917UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR2Cleared 510(K)
- K140025AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES2Cleared 510(K)
- K142275Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens2Cleared 510(K)
- K141699VASSEN COLOR2Cleared 510(K)
- K141670ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA2Cleared 510(K)
- K141280ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS2Cleared 510(K)
- K133403FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS2Cleared 510(K)
- K133735EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K133740SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT2Cleared 510(K)
- K132714ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)2Cleared 510(K)
- K133472SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)2Cleared 510(K)
- K133176AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL2Cleared 510(K)
- K133627AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS2Cleared 510(K)
- K132854EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K132715BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS2Cleared 510(K)
- K133079IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)2Cleared 510(K)
- K131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,2Cleared 510(K)
- K132146SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)2Cleared 510(K)
- K131378SUS (STENFILCON A) CONTACT LENS2Cleared 510(K)
- K130931EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K130342SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER2Cleared 510(K)
- K123431DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D2Cleared 510(K)
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- K121201SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K121652CVUE ADVANCED HYDRA VUE2Cleared 510(K)
- K121519ISIGHT2Cleared 510(K)
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- K113759AVAIRA (ENFILCON A) CONTACT LENS2Cleared 510(K)
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- K113245AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL2Cleared 510(K)
- K111267CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)2Cleared 510(K)
- K111345SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS2Cleared 510(K)
- K111966PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC2Cleared 510(K)
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- K110099PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT2Cleared 510(K)
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- K100443DEFINITIVE, FLEXLENS - SILICONE HYDROGEL2Cleared 510(K)
- K100244METRO SOFT2Cleared 510(K)
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- K091339BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K090806SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON2Cleared 510(K)
- K083288DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER2Cleared 510(K)
- K082883EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K082879EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K082880EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS2Cleared 510(K)
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- K080794POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K081865PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR2Cleared 510(K)
- K082393CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K080512REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT2Cleared 510(K)
- K073621INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT2Cleared 510(K)
- K080686WESTCON HORIZON 49% (HIOXIFILCON B)2Cleared 510(K)
- K073485VISTAKON (NARAFILCON) A SOFT CONTACT LENS2Cleared 510(K)
- K073459CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES2Cleared 510(K)
- K072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES2Cleared 510(K)
- K071736AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K062854BENZ-G 4X HIOXIFILCON D2Cleared 510(K)
- K062541CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K070308FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR2Cleared 510(K)
- K062262CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS2Cleared 510(K)
- K062614VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)2Cleared 510(K)
- K060821SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES2Cleared 510(K)
- K052290AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS2Cleared 510(K)
- K051477MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)2Cleared 510(K)
- K052606MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS2Cleared 510(K)
- K052560BIOFINITY (COMFILCON A) SOFT CONTACT LENS2Cleared 510(K)
- K052703ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL2Cleared 510(K)
- K05109555 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K051129DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K051430EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)2Cleared 510(K)
- K05118455 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K050948PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS2Cleared 510(K)
- K050717PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC2Cleared 510(K)
- K050157MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS2Cleared 510(K)
- K050743AQUAFLEX 2 (TEFILCON) CONTACT LENS2Cleared 510(K)
- K04030359% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS2Cleared 510(K)
- K043540HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES2Cleared 510(K)
- K043129PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)2Cleared 510(K)
- K042824FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENS2Cleared 510(K)
- K042435COOPER PROSTHETIC2Cleared 510(K)
- K042242ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES2Cleared 510(K)
- K041700CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K033655SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K041138LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS2Cleared 510(K)
- K041608C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS2Cleared 510(K)
- K040900S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K033919CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS2Cleared 510(K)
- K033136I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O22Cleared 510(K)
- K031774HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES2Cleared 510(K)
- K033969ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER2Cleared 510(K)
- K032873PROCLEAR COMPATIBLES MULTIFOCAL2Cleared 510(K)
- K032340VISTAKON (GALYFILCON A) SOFT CONTACT LENS2Cleared 510(K)
- K032256QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE2Cleared 510(K)
- K031532SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K031477HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K030842ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP2Cleared 510(K)
- K030593FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC2Cleared 510(K)
- K030748AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER2Cleared 510(K)
- K030548SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K030167MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER2Cleared 510(K)
- K030027GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%2Cleared 510(K)
- K023987CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)2Cleared 510(K)
- K023989CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)2Cleared 510(K)
- K024045CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)2Cleared 510(K)
- K024003GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT2Cleared 510(K)
- K024177ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER2Cleared 510(K)
- K023791NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K023349CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)2Cleared 510(K)
- K023732CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K023077OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)2Cleared 510(K)
- K023530HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)2Cleared 510(K)
- K021907IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K021720MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR2Cleared 510(K)
- N17676BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES2PMA Approval
- K021295SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K020855IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT2Cleared 510(K)
- K020642SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K020927BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS2Cleared 510(K)
- K020608HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)2Cleared 510(K)
- K020917SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K020690OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS2Cleared 510(K)
- K020392FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K020139FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN2Cleared 510(K)
- K020193OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K013973ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC2Cleared 510(K)
- K013649SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K013445OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES2Cleared 510(K)
- K013377BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K011893COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES2Cleared 510(K)
- K013469EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K013467TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K013220HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)2Cleared 510(K)
- K012425BIOMEDICS UV MULTIFOCAL2Cleared 510(K)
- P940013PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR2PMA Approval
- K011072GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS2Cleared 510(K)
- N17752HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS2PMA Approval
- K011256TORIC LITE LENS2Cleared 510(K)
- K002099S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-2Cleared 510(K)
- K001962S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-2Cleared 510(K)
- K011542SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)2Cleared 510(K)
- K011577OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S2Cleared 510(K)
- K011316BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T2Cleared 510(K)
- K011234BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L2Cleared 510(K)
- K011089SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C2Cleared 510(K)
- K004049POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)2Cleared 510(K)
- K010507VISTAKON (METHAFILCON A) CONTACT LENSES2Cleared 510(K)
- K010114ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)2Cleared 510(K)
- K010256ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL2Cleared 510(K)
- K010218VISTAKON (HEFILCON C) CONTACT LENSES2Cleared 510(K)
- K010223BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)2Cleared 510(K)
- K010126PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)2Cleared 510(K)
- K003861BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)2Cleared 510(K)
- K003996OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K004000OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT2Cleared 510(K)
- K003789SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT2Cleared 510(K)
- K003833SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K001585BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE2Cleared 510(K)
- K003526SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)2Cleared 510(K)
- K003042V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT2Cleared 510(K)
- K003136OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS2Cleared 510(K)
- K003170RYTHMIC AND RYTHMIC UV2Cleared 510(K)
- K003161ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT2Cleared 510(K)
- K003071GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K003079SPECIALTY TINT SOFT CONTACT LENS2Cleared 510(K)
- K002966OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K002408AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS2Cleared 510(K)
- N17752SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)2PMA Approval
- K002647MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS2Cleared 510(K)
- K002625METHAFILCON A2Cleared 510(K)
- K001908KONTUR 55 SOFT LENS2Cleared 510(K)
- K001227ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT2Cleared 510(K)
- K001620METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN2Cleared 510(K)
- K001584METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT2Cleared 510(K)
- K001089POLYMACON2Cleared 510(K)
- K001090METHAFILCON A2Cleared 510(K)
- K993489CRYSTAL CUSTOM TINTED SOFT CONTACT LENS2Cleared 510(K)
- K000529LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)2Cleared 510(K)
- K000376SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT2Cleared 510(K)
- K000439DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C2Cleared 510(K)
- K994335PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K000384FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX2Cleared 510(K)
- K994125BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES2Cleared 510(K)
- K994318VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER2Cleared 510(K)
- K994324ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER2Cleared 510(K)
- K993580SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K993935DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI2Cleared 510(K)
- K983637ACTIFRESH 400 LENS2Cleared 510(K)
- K992264OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS2Cleared 510(K)
- K992950CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS2Cleared 510(K)
- K991015LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)2Cleared 510(K)
- K992692EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS2Cleared 510(K)
- K992466OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- N17987CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS2PMA Approval
- K992589RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY2Cleared 510(K)
- K992500CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS2Cleared 510(K)
- K992339COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS2Cleared 510(K)
- K992054ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS2Cleared 510(K)
- K984090SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)2Cleared 510(K)
- K992010W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)2Cleared 510(K)
- K991000GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES2Cleared 510(K)
- K991163VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR2Cleared 510(K)
- K990815COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS2Cleared 510(K)
- K991550FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS2Cleared 510(K)
- K990011CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K984098ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS2Cleared 510(K)
- K991134ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR2Cleared 510(K)
- K990757CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA2Cleared 510(K)
- K990281S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K983496RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T2Cleared 510(K)
- K990606TETRAFILCON A2Cleared 510(K)
- K983160ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K984523IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K982947BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K983912VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER2Cleared 510(K)
- K984259PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)2Cleared 510(K)
- K984046BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS2Cleared 510(K)
- K982997FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)2Cleared 510(K)
- K982988PRECISION UV (VASURFILCON A)2Cleared 510(K)
- K983773BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS2Cleared 510(K)
- K982344DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS2Cleared 510(K)
- K983278OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)2Cleared 510(K)
- K983894BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS2Cleared 510(K)
- K983021METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC2Cleared 510(K)
- K982110POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K983053ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)2Cleared 510(K)
- K982774SOFT (HYDROPHILIC) CONTACT LENSES2Cleared 510(K)
- K982904ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K974837IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS2Cleared 510(K)
- K981779CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT2Cleared 510(K)
- K981252OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)2Cleared 510(K)
- K980649PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS2Cleared 510(K)
- K980634FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)2Cleared 510(K)
- K974408PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS2Cleared 510(K)
- K980554ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)2Cleared 510(K)
- K980818POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)2Cleared 510(K)
- K980218METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K974780SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS2Cleared 510(K)
- K974599ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS)2Cleared 510(K)
- K980418BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER2Cleared 510(K)
- K963013PREFERENCE 60 AND PREFERENCE 60 TORIC2Cleared 510(K)
- K973967AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)2Cleared 510(K)
- K973847AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS2Cleared 510(K)
- K973597AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS2Cleared 510(K)
- K973192FLEXLENS, FLEXLENS TORIC2Cleared 510(K)
- K972807(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI2Cleared 510(K)
- K973063FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K972303OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS2Cleared 510(K)
- K972454OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS2Cleared 510(K)
- K971647LL BI-FOCAL, DAILY WEAR CONTACT LENS2Cleared 510(K)
- K971164FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K971049FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)2Cleared 510(K)
- K971515PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)2Cleared 510(K)
- K965052D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES2Cleared 510(K)
- K970746SEE3 (LOTRAFILCON A) SOFT CONTACT LENS2Cleared 510(K)
- K970095PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS2Cleared 510(K)
- K970312CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)2Cleared 510(K)
- K970019MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS2Cleared 510(K)
- K970615PROMED 55-G SOFT DAILY WEAR CONTACT LENS2Cleared 510(K)
- K965012LIFESTYLE BREAK THRU (POLYMACON)2Cleared 510(K)
- K964902CONTACT LENSES METRO-G 3X (HIOXIFILCON B)2Cleared 510(K)
- K963001LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- P850077SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN2PMA Approval
- K964528(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT2Cleared 510(K)
- K964696SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS2Cleared 510(K)
- K964612VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT2Cleared 510(K)
- K963764SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR2Cleared 510(K)
- K963837HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN2Cleared 510(K)
- K962185HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K963011LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR2Cleared 510(K)
- K962911CONTACT LENS WITH COLOR ADDITIVE2Cleared 510(K)
- K963487DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS2Cleared 510(K)
- K963488SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)2Cleared 510(K)
- K961606METRO FOCAL ASPHERIC (POLYMACON)2Cleared 510(K)
- P940013PRECISION(TM) UV (VASURFILCON)2PMA Approval
- K962957RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT2Cleared 510(K)
- K962804ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER2Cleared 510(K)
- K962000FLEXLENS(METHAFILCON A)2Cleared 510(K)
- K961943FLEXLENS2Cleared 510(K)
- K961299PRECISION UV (VASURFILCON A)2Cleared 510(K)
- K962710GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K962711GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K962121HORIZON/WESTHIN 55-G2Cleared 510(K)
- K961103BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT2Cleared 510(K)
- P850079HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES2PMA Approval
- K961428SOFT-55 DAILY WEAR CONTACT LENS2Cleared 510(K)
- K950294FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K960926POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS2Cleared 510(K)
- K960376FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS2Cleared 510(K)
- K960380SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS2Cleared 510(K)
- K954524W-55 (METHAFILON A) CONTACT LENS2Cleared 510(K)
- K960291TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K953807DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K954603DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT2Cleared 510(K)
- K953199METRO 55G TORIC & SPHERICAL2Cleared 510(K)
- K952620OPTICAL BLANKS: BENZ55G CLEAR AND VISIBILITY TINTED2Cleared 510(K)
- P860040BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES2PMA Approval
- K954139AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K951893LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS2Cleared 510(K)
- K953804VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS2Cleared 510(K)
- N17752HYDROCURVE (BUFILCON A CONTACT LENSES)2PMA Approval
- K952152PROCLEAR DAILY WEAR CONTACT LENS2Cleared 510(K)
- K950968TETRAFILCON A HYDROPHILIC CONTACT LENSES2Cleared 510(K)
- K952261HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%2Cleared 510(K)
- P850077SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN2PMA Approval
- P850079HYDRASOFT KERATOCONUS METHAFILCON B2PMA Approval
- P850077REVOLUTIONS (TM) ALT. MANU. SITE CONTACTS2PMA Approval
- P850077SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN2PMA Approval
- P940013PRECISION(TM) UV (VASURFILCON)2PMA Approval
- K942374ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS2Cleared 510(K)
- K951180ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K943178DELTA2Cleared 510(K)
- K940848GELFLEX2Cleared 510(K)
- K950818HORIZON 55 BI-CON TORIC2Cleared 510(K)
- N18033VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS2PMA Approval
- P940013PRECISION(TM) UV (VASURFILCON)2PMA Approval
- K950283LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K945981LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K946012PRECISION UV(TM) (VASURFICON A)2Cleared 510(K)
- K945365HORIZON 55 BI-CON2Cleared 510(K)
- K944895BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS2Cleared 510(K)
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P940013PRECISION(TM) UV (VASURFILCON)2PMA Approval
- N17752HYDROCURVE2PMA Approval
- K941998OCU-FLEX-38 (POLYMACON)2Cleared 510(K)
- K944722PRECISION UV(TM) (VASURFILCON A)2Cleared 510(K)
- K942494LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K943490CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES2Cleared 510(K)
- K942302ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS2Cleared 510(K)
- K942214H55 HYDROPHILIC CONTACT LENS2Cleared 510(K)
- K942187ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- K942186ESSTECH PS ASPHERIC2Cleared 510(K)
- K942372SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS2Cleared 510(K)
- K941836UNILENS 38 SOFT ASPHERIC CONTACT LENS2Cleared 510(K)
- P890049FINISHED METHAFILCON A CONTACT LENSES2PMA Approval
- P850079HYDRASOFT KERATOCONUS METHAFILCON B2PMA Approval
- K941877LL-55 (METHAFILCON A) FOR DAILY WEAR2Cleared 510(K)
- P880101AQUAFLEX DAILY & EXTENDED WEAR HYDROPHILIC LENS2PMA Approval
- K941484DAILY WEAR SOFT CONTACT LENSES2Cleared 510(K)
- K941607UCL MULTIFOCAL SOFT CONTACT LENS2Cleared 510(K)
- K941370BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS2Cleared 510(K)
- K940777BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS2Cleared 510(K)
- P830006SOFTACT II (POLYMACON)2PMA Approval
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P910029\YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES2PMA Approval
- P780007POLYMACON CONTACT LENSES2PMA Approval
- P820059POLYMACON CONTACT LENSES2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- P850002SIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS2PMA Approval
- P850002UNILENS (HEFILCON A) CONTACT LENS2PMA Approval
- N18033VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS2PMA Approval
- N18033ACUVUE(R) (ETAFILICON A) HYDROPHILIC CONTACT LENS2PMA Approval
- P820059POLYMACON CONTACT LENSES2PMA Approval
- P890029EXCELENS (ATLAFILCON A) CONTACT LENS2PMA Approval
- N17676BAUSCH & LOMB (HEFILCON C) CONTACT LENSES2PMA Approval
- P910029HYDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17987CSI COLOURS CONTACT LENSES2PMA Approval
- P880102LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L2PMA Approval
- P780007POLYMACON CONTACT LENSES2PMA Approval
- P850079HYDRASOFT KERATOCONUS METHAFILCON B2PMA Approval
- P880098MENICON SUPER EX CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES2PMA Approval
- P850079HYDRASOFT (METHAFILCON B) CONTACT LENS2PMA Approval
- P820051PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS2PMA Approval
- P900065TECHNICON-38 POLYMACON HYDROPHILIC LENS2PMA Approval
- P850077SEDUCTIONS(TM) (METHAFILCON A) HYDROPHILIC LENS2PMA Approval
- P820051OCU-FLEX-53 SOFT CONTACT LENSES2PMA Approval
- P890029CIBA 2000(TM) (ATLAFILCON A) SOFT CONTACT LENS2PMA Approval
- P880098MENICON SUPER EX CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES2PMA Approval
- P880049EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES2PMA Approval
- P830006SOFTACT II (POLYMACON)2PMA Approval
- P880102LOMBART (POLYMACON) SOFT CONTACT LENSES2PMA Approval
- P820059POLYMACON CONTACT LENSES2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P810005CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS2PMA Approval
- P880101AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE2PMA Approval
- N17676TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES2PMA Approval
- N17676TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES2PMA Approval
- N17676BAUSCH & LOMB (HEFILCON C) CONTACT LENSES2PMA Approval
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS2PMA Approval
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES2PMA Approval
- N17852DURASOFT CONTACT LENSES /SHELF LIFE2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P900058FLEXLENS (HEFILCON A) SOFT CONTACT LENSES2PMA Approval
- P900065TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES2PMA Approval
- P850002ALGES(TM) (HEFILCON A) CONTACT LENS2PMA Approval
- P850077REVOLUTION(TM) (METHAFILCON A) HYDROPHILIC LENS2PMA Approval
- P820051STERILIZED FINISHED OCUFILCON B LENSES2PMA Approval
- P780013V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P890049FINISHED METHAFILCON A CONTACT LENSES2PMA Approval
- P880049EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES2PMA Approval
- N17676BAUSCH & LOMB (HEFILCON C) CONTACT LENSES2PMA Approval
- P850002ALGES(TM) (HEFILCON A) CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON B) VISIBILITY TINT LENSES2PMA Approval
- P890031OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI2PMA Approval
- P840006SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P890031OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI2PMA Approval
- P780013TRI POL 43 CONTACT LENS2PMA Approval
- P820051CONTACT LENSES2PMA Approval
- N17676TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES2PMA Approval
- P840006SOF-FORM ALLVUE MULTIFOCAL (POLYMACON) CONTACT LEN2PMA Approval
- N18033VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P890031OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P8600401PHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P880098MENICON SF-P RGP (MELAFOCON A) CONTACT LENS2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P880101AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE2PMA Approval
- P890053O.P.R. -55 SOFT CONTACT LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS2PMA Approval
- P820005(POLYMACON) SOF-FORM II CONTACT LENSES2PMA Approval
- P840006SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P880101AQUAFLEX[TETRAFILCON A] CONTACT LENSES2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- N17976FLEXENS (HEFILCON A) SOFT CONTACT LENS2PMA Approval
- P820051STERILIZED FINISHED OCUFILCON B LENSES2PMA Approval
- P830012SOFTICS(TM) (POLYMACON)2PMA Approval
- P830006SOFTACT II (POLYMACON)2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P880098MENICON SF-P RGP (MELAFOCON A) CONTACT LENS2PMA Approval
- P870079TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS2PMA Approval
- P870019ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS2PMA Approval
- P890029EXCELENS (ATLAFILCON A) CONTACT LENS2PMA Approval
- P890053O.P.R. -55 SOFT CONTACT LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17852DURASOFT CONTACT LENSES /SHELF LIFE2PMA Approval
- P880101AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P880098MENICON SF-P RGP (MELAFOCON A) CONTACT LENS2PMA Approval
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS2PMA Approval
- P820005(POLYMACON) SOF-FORM II CONTACT LENSES2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- N17554SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P830006SOFTACT II (POLYMACON)2PMA Approval
- P870079TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N17976FLEXLENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- N18033ISTAMARC TORIC (ETAFILCONA))2PMA Approval
- P7800079YDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N18033ISTAMARC TORIC (ETAFILCONA))2PMA Approval
- P890029EXCELENS (ATLAFILCON A) CONTACT LENS2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- P870019ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS2PMA Approval
- P860040NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P870019ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS2PMA Approval
- P880098MENICON SF-P RGP (MELAFOCON A) CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N18033ISTAMARC TORIC (ETAFILCONA))2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P890049FINISHED METHAFILCON A CONTACT LENSES2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P890012SIGNATURE CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P860040NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P850002ALGES(TM) (HEFILCON A) CONTACT LENS2PMA Approval
- P870079TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P870079TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS2PMA Approval
- P860009IGEL 67 CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P800031(MAFILCON) SOFT CONTACT LENSES2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P860040NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- P850002ALGES(TM) (HEFILCON A) CONTACT LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P830077METRO 55 (METHAFILCON A)2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P830077METRO 55 (METHAFILCON A)2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N17554SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P850002ALGES(TM) (HEFILCON A) CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P820051STERILIZED FINISHED OCUFILCON B LENSES2PMA Approval
- N18033ISTAMARC TORIC (ETAFILCONA))2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P830012SOFTICS(TM) (POLYMACON)2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- N17855TRESOFT SOFT CONTACT LENSE2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17976FLEXLENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- N17976FLEXLENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- N18033VISTAMARC TORIC (ETAFILCON A)2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P830003SOFTVIEW SPHERICAL & TORIC CONTACT LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- N18033ISTAMARC TORIC (ETAFILCONA))2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P840071TINTED TETRAFILCON A CONTACT LENSES2PMA Approval
- P860009IDEL 67 CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N18033ISTAMARC TORIC (ETAFILCONA))2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- P830003SOFTVIEW SPHERICAL & TORIC CONTACT LENS2PMA Approval
- P830003SOFTVIEW SPHERICAL & TORIC CONTACT LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- N17554SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P830012SOFTICS(TM) (POLYMACON)2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N18033VISTAMARC TORIC (ETAFILCON A)2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P820005(POLYMACON) CONTACT LENSES2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- P850033SCANLENS (SCAFILCON A CONTACT LENS)2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) LENS2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P820051OCU-FLEX2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- N17855TRESOFT SOFT CONTACT LENSE2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P830006SOFTACT II (POLYMACON)2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N18001MINITHEERM2PMA Approval
- P830006SOFTACT II (POLYMACON)2PMA Approval
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS2PMA Approval
- P850072DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS2PMA Approval
- P850078KONTUR SOFT (METHAFILCON A) CONTACT LNS2PMA Approval
- P850079HYDRASOFT (METHAFILCON A) CONTACT LENS2PMA Approval
- N17375SOFTCON BANDAGE LENS2PMA Approval
- N17554SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17375SOFTCON BANDAGE LENS2PMA Approval
- N17554SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS2PMA Approval
- N18001MINITHEERM2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- P850058CUSTOMEYES 70L & 79L (LIDOFILCON A&B)2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P850057CUSTOMEYES(TM) 45L&55L (BUFILCON A)2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- N17554SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS2PMA Approval
- N17734ACCUSEPT DISINFECTING UNIT2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- P850002ALGES(TM) (HEFILCON A) CONTACT LENS2PMA Approval
- P820051OCU-FLEX2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P800020SILSOFT (ELASTOFILCON A ) CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- P820026METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P840006SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- N17734ACCUSEPT DISINFECTING UNIT2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- P780007C&H SOFT (POLYMACON) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17375SOFTCON BANDAGE LENS2PMA Approval
- N18001MINITHEERM2PMA Approval
- N17554SOFTCON CONTACT LENS2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- N17852DURASOFT(R) 2 BIFOCAL2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P800070SOFTACT(TM) (DELTAFILCON A)2PMA Approval
- P840006SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P830006SOFTACT II (POLYMACON)2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P820086CIBATINT(TM) TINTING PROCESS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N17752HYDROCURVE II BIFOCAL LENS2PMA Approval
- P830070AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR2PMA Approval
- N17976FLEXLENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- N18018ARMSOF SOFT CONTACT LENSE2PMA Approval
- P810050OPTECH FRE-FLEX SOFT CONTACT LENS2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17734ACCUGEL 1T2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- P800070SOFTACT(TM) (DELTAFILCON A)2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- N17855TRESOFT SOFT CONTACT LENSE2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- P780013TRI POL 43 CONTACT LENS2PMA Approval
- P820078AL-47 SOFT CONTACT LENS2PMA Approval
- P820059PERMATINT(R)2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P810050OPTECH FRE-FLEX SOFT CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- P800020SILSOFT (ELASTOFILCON A ) CONTACT LENS2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- P820017HYDRACON(R) CONTACT LENSES2PMA Approval
- N17852DURASOFT(R) TRUFOCAL(TM)2PMA Approval
- P800070SOFTACT(TM) (DELTAFILCON A)2PMA Approval
- P820005CELUSOFT (POLYMACON) LENS2PMA Approval
- P800020SILSOFT (ELASTOFILCON A ) CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N17976FLEXLENS2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P800020SILSOFT (ELASTOFILCON A ) CONTACT LENS2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- N18033VISTAMARC(TM) CONTACT LENS2PMA Approval
- N18162AQUA SOFT CONTACT LENS2PMA Approval
- P810057COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- P800020SILSOFT (ELASTOFILCON A ) CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P820005(POLYMACON) CONTACT LENSES2PMA Approval
- N17855TRESOFT SOFT CONTACT LENSE2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS2PMA Approval
- N18001MINITHEERM2PMA Approval
- N18001MINITHEERM2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- N17734ACCUSEPT DISINFECTING UNIT2PMA Approval
- N17752HYDROCURVE II2PMA Approval
- N17793SOFTSITE (HEFILCON A) CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P800070SOFTACT(TM) (DELTAFILCON A)2PMA Approval
- N17722GELFLEX(R) (DIMEFILCON A) CONTACT LENS2PMA Approval
- P800020SILSOFT (ELASTOFILCON A ) CONTACT LENS2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- P800054SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR2PMA Approval
- N18180CUSTOMFLEX CONTACT LENS2PMA Approval
- P800013METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17752HYDROCURVE II (BUFILCON A) CONTACT LENSES2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N18146SOF FORM (DELTAFILCON A)2PMA Approval
- N18146SOF FORM (DELTAFILCON A)2PMA Approval
- N18001TETRAFILCON A HYDROPHILIC CONTACT LENS2PMA Approval
- N17676MIRACON (HEFILCON B) TORIC CONTACT LENS2PMA Approval
- P800013METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17852DURASOFT SX4 & DURASOFT SX4 (PHEMFILCON A )2PMA Approval
- P800020SILSOFT (ELASTOFILCON A) CONTACT LENS2PMA Approval
- N17752HYDROCURVEII (BUFILCON A) CONTACT LENSES2PMA Approval
- N18033HYDRO-MARC (ETALFILCON A) CONTACT LENES2PMA Approval
- N18146SOF FORM (DELTAFILCON A)2PMA Approval
- N17793SOFT SITE (HEFILCON A) CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17752HYDROCURVE II (BUFILCON A) CONTACT LENSES2PMA Approval
- P780007HYDRON HYDROPHILIC CONTACT LENS2PMA Approval
- N18180CUSTOMFLEX CONTACT LENS2PMA Approval
- N18180CUSTOMFLEX (DELTAFILCON A) HYDROPHILIC CONTACT LEN2PMA Approval
- P800011WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N17375SOFTCON BANDAGE LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P780007HYDRON SEMI SCLERAL, MINI, TORIC2PMA Approval
- N17793SOFT SITE (HEFILCON A) CONTACT LENS2PMA Approval
- N17976FLEXLENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N17987SOFT CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P780013TRI POL 43 CONTACT LENS2PMA Approval
- N17676MIRACON(TM) (HEFILCON B)2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P780007HYDRON SEMI SCLERAL, MINI, TORIC2PMA Approval
- N18018ARMSOF SOFT CONTACT LENSE2PMA Approval
- N18146SOF FORM CONTACT LENSE2PMA Approval
- N17855TRESOFT SOFT CONTACT LENSE2PMA Approval
- P790015SOFTICS (DELTAFILCON A) LENS2PMA Approval
- N17793SOFT SITE (HEFICON A)2PMA Approval
- P780007HYDRON SEMI SCLERAL, MINI, TORIC2PMA Approval
- N17375SOFTCON BANDAGE LENS2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- P780007HYDRON SEMI SCLERAL, MINI, TORIC2PMA Approval
- N17722GELFLEX(R) (DIMEFILCON A) CONTACT LENS2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N18146SOF FORM (DELTAFILCON A)2PMA Approval
- P780007HYDRON SEMI SCLERAL, MINI, TORIC2PMA Approval
- N17951TRI POL 43 CONTACT LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17752HYDROCURVE2PMA Approval
- P780013TRI POL 43R HYDROPHILIC CONTACT LENS2PMA Approval
- P780007HYDRON SEMI SCLERAL, MINI, TORIC2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17855TRESOFT SOFT CONTACT LENSE2PMA Approval
- N18033HYDRO MARC LENSES (HYDROPHILIC)2PMA Approval
- N18018ARMSOF SOFT CONTACT LENSE2PMA Approval
- N17852DURASOFT CONTACT LENS2PMA Approval
- N18162AQUA-SOFT (DELTAFILC2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N17722GELFLEX(R) (DIMEFILCON A) CONTACT LENS2PMA Approval
- N17375SOFTCON BANDAGE LENS2PMA Approval
- N17722GELFLEX(R) (DIMEFILCON A) CONTACT LENS2PMA Approval
- N18001MINITHEERM2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- N18180TRIPOL 432PMA Approval
- N18162TRI POL2PMA Approval
- N18146SOFFORM CONTACT LENS2PMA Approval
- N18018ARMSOF SOFT CONTACT LENSE2PMA Approval
- N17752HYDROCURVE2PMA Approval
- N17951TRI POL 43 CONTACT LENS2PMA Approval
- N17722GELFLEX(R) (DIMEFILCON A) CONTACT LENS2PMA Approval
- N17951TRI POL 43 CONTACT LENS2PMA Approval
- N17676NATUREVUE CONTACT LENSE2PMA Approval
- LPMLenses, Soft Contact, Extended Wear3Product Code
- LPNAccessories, Soft Lens Products2Product Code
- LRXCase, Contact Lens2Product Code
- LYLAccessories, Solution, Ultrasonic Cleaners For Lenses2Product Code
- MMLWeights, Eyelid, External2Product Code
- MRCProducts, Contact Lens Care, Rigid Gas Permeable2Product Code
- MUWLens, Contact (Orthokeratology)2Product Code
- MVNLens, Contact, (Disposable)2Product Code
- MWLLens, Contact (Rigid Gas Permeable), Extended Wear3Product Code
- MZDSystem, In-Office Tinting, Contact Lenses2Product Code
- NAILens, Prescription, Color Deficiency1Product Code
- NCBWeights, Eyelid, Implantable2Product Code
- NCZLens, Contact, For Color Vision Deficiency2Product Code
- NICLens, Contact, For Reading Discomfort2Product Code
- NJHLens, Spectacle (Prescription), For Reading Discomfort1Product Code
- NUULens, Contact, Orthokeratology, Overnight3Product Code
- ORZEyelid Thermal Pulsation System2Product Code
- PICOral Electronic Vision Aid2Product Code
- PLXTear Duct Occluder1Product Code
- PQJIntranasal Electrostimulation Device2Product Code
- QBRIntranasal Electrostimulation Device For Dry Eye Symptoms2Product Code
- QIUIntense Pulsed Light Device For Managing Dry Eye2Product Code
- QKVElectromechanical Tear Stimulator2Product Code
- QMMHydrophilic Re-Coating Solution2Product Code
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K974837
- 510(k) Type
- Traditional
- Applicant
- Igel Vision Care Pte , Ltd.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/6/1998
- Days to Decision
- 194 days
- Submission Type
- Summary