510(k) Report

Devices descending from K051430

22 later devices reach Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181050Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20180—
+1K161124EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily WearVision Science Co., Ltd.20160—
+1K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58…INTEROJO, Inc.201612—
+1K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp.20077—
+2K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc.20221—
+2K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20227—
+2K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensUnicon Optical Co., Ltd.20191—
+2K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49…Contamac, Ltd.20151—
+2K101122Benz-G 4X (Hioxifilcon D) Multifocal Lathed LensBenz Research and Development Corp.20100—
+2K082393Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA20083—
+3K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd.20250—
+3K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd.20240—
+3K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+3K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation20232—
+3K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+3K153305EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL…Eyeyon Medical20160—
+3K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA20110—
+3K100456Cvue Advanced DefinitiveUnilens Corp., USA20102—
+4K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation20241—
+4K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc.20240—
+4K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—
+5K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation20250—