510(k) Report

Devices descending from K020389

22 later devices reach Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131378Sus (Stenfilcon a) Contact LensCooperVision, Inc.2013105
+1K113267BIOPMEDICS52,52 1DAY,52 Toric,52 1DAY ToricCooperVision, Inc.20110—
+1K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc.200691
+2K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd.20220—
+2K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20201—
+2K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…CooperVision, Inc.20202—
+2K190965MyDayCooperVision, Inc.201914
+2K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd20174—
+2K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc.201631
+2K112302Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…CooperVision, Inc.20116—
+2K111966Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XCCooperVision, Inc.20110—
+2K110099Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…CooperVision, Inc.20117—
+3K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20260—
+3K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd.20241—
+3K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…CooperVision, Inc.202205
+3K213164Avaira VitalityCooperVision, Inc.202111
+3K201013Optixon 1-DayOptixon, Inc.20200—
+3K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated20180—
+3K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd20181—
+3K123202Proclear (Omafilcon a) Soft Hydrophilic) Contact LensCooperVision, Inc.201301
+4K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd.20260—
+4K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…Geo Medical CO., LTD.20260—