510(k) Report

Devices descending from K043129

14 later devices reach Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts20072—
+1K050717Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal…CooperVision, Inc.200510—
+2K111966Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XCCooperVision, Inc.20110—
+2K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+2K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc.200691
+3K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—
+3K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd.20220—
+3K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd20174—
+3K112302Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…CooperVision, Inc.20116—
+3K110099Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…CooperVision, Inc.20117—
+4K201013Optixon 1-DayOptixon, Inc.20200—
+4K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd20181—
+4K123202Proclear (Omafilcon a) Soft Hydrophilic) Contact LensCooperVision, Inc.201301
+5K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…Geo Medical CO., LTD.20260—