510(k) Report

Devices descending from K162361

2 later devices reach Soft Plug Extended Duration 180 Canalicular Plug through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241229Hello,eyes® BIO PlugBio Optics Co., Ltd.20240—
+1K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc.20220—