510(k) Report

Devices descending from K100221

32 later devices reach INTELLIWAVE3 through their predicates, nearest generation first.

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