510(k) Report

Devices descending from K000384

13 later devices reach Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130931Easy Day (Methafilcon a) 1-Day Soft (Hydrophilic) Contact LensJiangsu Horien Contact Lens Co., Ltd.20130—
+1K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensCl Mcintosh200211—
+2K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc.201091
+2K031477Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact LensOcular Sciences, Inc.20030—
+3K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc.20182—
+3K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV…Largan Medical Co., Ltd.20183—
+3K141280Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd.20141—
+4K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc.20250—
+4K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB…Largan Medical Co., Ltd.20210—
+4K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesVizionfocus, Inc.20190—
+4K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20182—
+4K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+5K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20250—