510(k) Report

Devices descending from K131378

10 later devices reach Sus (Stenfilcon a) Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20201—
+1K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…CooperVision, Inc.20202—
+1K190965MyDayCooperVision, Inc.201914
+1K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc.201631
+2K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20260—
+2K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd.20241—
+2K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…CooperVision, Inc.202205
+2K213164Avaira VitalityCooperVision, Inc.202111
+2K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated20180—
+3K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd.20260—