510(k) Report

Devices descending from K160212

5 later devices reach ACUVUE (senofilcon C) Soft Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242391Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact LensLucens Technology Co., Ltd.20240—
+1K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+1K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensUnicon Optical Co., Ltd.20221—
+2K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd.20240—
+2K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc.20240—