510(k) Report

Devices descending from K964528

51 later devices reach (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49…Contamac, Ltd.20151—
+1K120756LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a)…The Lagado Corp.20132—
+1K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue…Art Optical Contact Lens, Inc.200833—
+1K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co.20080—
+1K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC20060—
+1K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and…Contamac, Ltd.200334—
+1K983496Resolution 45 (Spherical) and Ultra Gel (Toric) (Hioxifilcon B) Soft Daily Wear Contact…Opti-Centre Laboratories19990—
+1K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Alden Optical Labs., Inc.19983—
+1K982904Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact LensLes Laboratoires Blanchard19983—
+1K981252Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue…Alden Optical Labs., Inc.199862
+1K974599Ultravue/P, Ultralvue/C (Hioxifilcon B)) Soft (Multifocal) Daily Wear Contact Lens…Opti-Centre Laboratories19980—
+2K153305EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL…Eyeyon Medical20160—
+2K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS…Abb Optical Group, LLC20150—
+2K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc.20140—
+2K133079IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric…Alden Optical Labs., Inc.20131—
+2K100221INTELLIWAVE3Art Optical Contact Lens, Inc.201032—
+2K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts20072—
+2K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp.19992—
+3K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Art Optical Contact Lens, Inc.20232—
+3K191121Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for…Lentechs, LLC20190—
+3K142641Intelliwave4Art Optical Contact Lens, Inc.201512—
+3K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—
+3K121519IsightC&E GP Specialists, Inc.20120—
+3K121324Avt NaturasoftAdvanced Vision Technologies20120—
+3K111267Concise, Silicone Hydrogel Daily Wear Soft Contact Lens (Efrofilcon a)Abbconcise Optical Group, LLC20110—
+3K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+3K100456Cvue Advanced DefinitiveUnilens Corp., USA20102—
+3K100244Metro SoftMetro Optics of Austin, Inc.20108—
+3K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd.20040—
+3K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc.20020—
+4K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—
+4K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics of Austin, Inc.20240—
+4K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc.201511—
+4K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+4K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA20110—
+5K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC20170—
+5K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+5K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.20168—
+5K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc.20160—
+6K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20214—
+6K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E…Valley Contax, Inc.20210—
+6K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…Paragon Vision Sciences20180—
+6K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.20171—
+6K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+7K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc.20243—
+7K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+8K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+8K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc.20240—
+8K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.20240—
+8K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight20240—
+9K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—