510(k) Report

Devices descending from DEN230055

1 later device reach FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252455FSYX Ocular Pressure Adjusting PumpBalance Ophthalmics, Inc.20260—