510(k) Report

Devices descending from K200325

3 later devices reach Orbit Subretinal Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+1K203264MicroDose InjectorMedone Surgical, Inc.20212—
+2K250501System SophiThis AG20250—