510(k) Report

Devices descending from DEN080006

36 later devices reach Ulthera System, Model 8850-0001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121700Ulthera SystemUlthera, Inc.201217—
+1K122528Ulthera SystemUlthera, Inc.20120—
+1K100874Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation201116—
+2K132028Ulthera SystemUlthera, Inc.201316—
+2K112626Lipsonix (R) System Model 2Medicis Technologies Corporation201115—
+3K230100Scizer (SC1-M410)Classys, Inc.20230—
+3K181896LIPOcelJeisys Medical, Inc.20191—
+3K134032Ulthera SystemUlthera, Inc.201415—
+3K133238Contour I V3.1 SystemSyneron Medical, Ltd.201411—
+4K231628BeShape One™ DeviceBeshape Technologies, Ltd.20230—
+4K191421Sofacia SystemSofwave Medical, Ltd.20190—
+4K180623Ulthera SystemUlthera, Inc.201813—
+4K160896Ultrashape Power SystemSyneron Medical, Ltd.20166—
+4K141708Ultrashape SystemSyneron Medical, Ltd.201410—
+5K233996Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc.20243—
+5K211483SofWave SystemSofwave Medical, Ltd.20218—
+5K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+5K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+5K170370Ultrashape Power SystemSyneron Medical, Ltd.20170—
+5K162163UltraShape SystemSyneron Medical, Ltd.20161—
+5K161952UltraShape SystemSyneron Medical, Ltd.20161—
+6K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc.20251—
+6K243035Ulthera® SystemUlthera, Inc.20252—
+6K223237SofWave SystemSofwave Medical, Ltd.20227—
+6K202430Kerecis ReconstructKerecis Limited20213—
+7K260618Ulthera® SystemUlthera, Inc.20260—
+7K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+7K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+7K243843Tendon Protect (50242)Kerecis Limited20250—
+7K230019SofWave SystemSofwave Medical, Ltd.20236—
+8K230820SofWave SystemSofwave Medical, Ltd.20235—
+9K232455SofWave SystemSofwave Medical, Ltd.20234—
+10K240687SofWave SystemSofwave Medical, Ltd.20243—
+11K241685SofWave SystemSofwave Medical, Ltd.20242—
+12K250146SofWave SystemSofwave Medical, Ltd.20251—
+13K251746Pure ImpactSofwave Medical, Ltd.20250—