510(k) Report

Devices descending from K112626

15 later devices reach Lipsonix (R) System Model 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230100Scizer (SC1-M410)Classys, Inc.20230—
+1K181896LIPOcelJeisys Medical, Inc.20191—
+1K133238Contour I V3.1 SystemSyneron Medical, Ltd.201411—
+2K231628BeShape One™ DeviceBeshape Technologies, Ltd.20230—
+2K160896Ultrashape Power SystemSyneron Medical, Ltd.20166—
+2K141708Ultrashape SystemSyneron Medical, Ltd.201410—
+3K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K170370Ultrashape Power SystemSyneron Medical, Ltd.20170—
+3K162163UltraShape SystemSyneron Medical, Ltd.20161—
+3K161952UltraShape SystemSyneron Medical, Ltd.20161—
+4K202430Kerecis ReconstructKerecis Limited20213—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—