510(k) Report

Devices descending from DEN150022

6 later devices reach Ultravision Visual Clearing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170178Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd.20175—
+2K182053Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd.20184—
+3K200035Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd.20203—
+4K240868Ultravision2™ IonPencilAlesi Surgical Limited20240—
+4K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd.20231—
+4K231238Ultravision2™ SystemAlesi Surgical, Ltd.20230—