510(k) Report

Devices descending from K133238

11 later devices reach Contour I V3.1 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160896Ultrashape Power SystemSyneron Medical, Ltd.20166—
+1K141708Ultrashape SystemSyneron Medical, Ltd.201410—
+2K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+2K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+2K170370Ultrashape Power SystemSyneron Medical, Ltd.20170—
+2K162163UltraShape SystemSyneron Medical, Ltd.20161—
+2K161952UltraShape SystemSyneron Medical, Ltd.20161—
+3K202430Kerecis ReconstructKerecis Limited20213—
+4K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+4K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+4K243843Tendon Protect (50242)Kerecis Limited20250—