510(k) Report

Devices descending from K180623

13 later devices reach Ulthera System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233996Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc.20243—
+1K211483SofWave SystemSofwave Medical, Ltd.20218—
+2K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc.20251—
+2K243035Ulthera® SystemUlthera, Inc.20252—
+2K223237SofWave SystemSofwave Medical, Ltd.20227—
+3K260618Ulthera® SystemUlthera, Inc.20260—
+3K230019SofWave SystemSofwave Medical, Ltd.20236—
+4K230820SofWave SystemSofwave Medical, Ltd.20235—
+5K232455SofWave SystemSofwave Medical, Ltd.20234—
+6K240687SofWave SystemSofwave Medical, Ltd.20243—
+7K241685SofWave SystemSofwave Medical, Ltd.20242—
+8K250146SofWave SystemSofwave Medical, Ltd.20251—
+9K251746Pure ImpactSofwave Medical, Ltd.20250—