510(k) Report

Devices descending from K954603

5 later devices reach Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013377Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc.20014—
+2K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20182—
+2K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+3K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20250—
+3K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB…Largan Medical Co., Ltd.20210—