510(k) Report

Devices descending from K942214

22 later devices reach H55 Hydrophilic Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992264Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.19991—
+1K982947Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc.199913—
+1K984046Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc.199915—
+1K972303Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.199721—
+2K082880Ezvue (Ocufilcon D) 1-Day Soft (Hydrophilic)Contact LensI-See Vision Technology, Inc.20090—
+2K082879Ezvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily WearI-See Vision Technology, Inc.20094—
+2K031477Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact LensOcular Sciences, Inc.20030—
+2K030748Aquasoft (Ocufilcon D) Daily Wear Contact Lens Clear and Visibility Tint, with UV BlockerClearlab Pte, Ltd.20030—
+2K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensCl Mcintosh200211—
+2K013377Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc.20014—
+2K012425Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc.200110—
+3K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20182—
+3K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+3K150293EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear…I-See Vision Technology, Inc.20153—
+3K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc.201091
+4K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc.20250—
+4K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20250—
+4K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB…Largan Medical Co., Ltd.20210—
+4K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc.20182—
+4K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV…Largan Medical Co., Ltd.20183—
+4K141280Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd.20141—
+5K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesVizionfocus, Inc.20190—