510(k) Report

Devices descending from K153766

12 later devices reach Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc.20221—
+1K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20227—
+1K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensUnicon Optical Co., Ltd.20191—
+1K161124EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily WearVision Science Co., Ltd.20160—
+2K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd.20250—
+2K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd.20240—
+2K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+2K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation20232—
+2K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+3K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation20241—
+3K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc.20240—
+4K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation20250—