510(k) Report

Devices descending from K130025

3 later devices reach Sonendo Endotherapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133752Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure KitSonendo, Inc.20142—
+2K143448Sonendo GentleWave SystemSonendo, Inc.20151—
+3K233844OdneCleanOdne AG20240—