510(k) Report

Devices descending from K213216

1 later device reach Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd.20240—