510(k) Report

Devices descending from K952620

38 later devices reach Optical Blanks: BENZ55G Clear and Visibility Tinted through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023349Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and…Contamac, Ltd.200235—
+1K992589Resolution 5X (Spherical) and Ultra Gel 5X (Toric)(Hioxifilcon a) Soft Daily Wear…Opti-Centre Laboratories19990—
+1K981779Cantor & Silver 5X (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear Contact Lens…Cantor & Silver, Ltd.19980—
+2K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and…Contamac, Ltd.200334—
+3K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue…Art Optical Contact Lens, Inc.200833—
+4K100221INTELLIWAVE3Art Optical Contact Lens, Inc.201032—
+5K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Art Optical Contact Lens, Inc.20232—
+5K191121Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for…Lentechs, LLC20190—
+5K142641Intelliwave4Art Optical Contact Lens, Inc.201512—
+5K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc.20140—
+5K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—
+5K121519IsightC&E GP Specialists, Inc.20120—
+5K121324Avt NaturasoftAdvanced Vision Technologies20120—
+5K111267Concise, Silicone Hydrogel Daily Wear Soft Contact Lens (Efrofilcon a)Abbconcise Optical Group, LLC20110—
+5K100456Cvue Advanced DefinitiveUnilens Corp., USA20102—
+5K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+5K100244Metro SoftMetro Optics of Austin, Inc.20108—
+6K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—
+6K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics of Austin, Inc.20240—
+6K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc.201511—
+6K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+6K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA20110—
+7K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC20170—
+7K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+7K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.20168—
+7K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc.20160—
+8K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20214—
+8K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E…Valley Contax, Inc.20210—
+8K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…Paragon Vision Sciences20180—
+8K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.20171—
+8K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+9K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc.20243—
+9K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+10K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+10K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc.20240—
+10K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.20240—
+10K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight20240—
+11K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—