510(k) Report

Devices descending from DEN160037

6 later devices reach dermaPACE System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AG20211—
+1K191961OrthoGoldTissue Regeneration Technologies20195—
+2K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A20250—
+2K231710OW100SSoftwave/Trt, LLC20231—
+2K200926OrthoGold 100Tissue Regeneration Technologies, LLC20202—
+3K233937OW100SSoftwave/Trt, LLC20240—