510(k) Report

Devices descending from K134032

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191421Sofacia SystemSofwave Medical, Ltd.20190—
+1K180623Ulthera SystemUlthera, Inc.201813—
+2K233996Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc.20243—
+2K211483SofWave SystemSofwave Medical, Ltd.20218—
+3K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc.20251—
+3K243035Ulthera® SystemUlthera, Inc.20252—
+3K223237SofWave SystemSofwave Medical, Ltd.20227—
+4K260618Ulthera® SystemUlthera, Inc.20260—
+4K230019SofWave SystemSofwave Medical, Ltd.20236—
+5K230820SofWave SystemSofwave Medical, Ltd.20235—
+6K232455SofWave SystemSofwave Medical, Ltd.20234—
+7K240687SofWave SystemSofwave Medical, Ltd.20243—
+8K241685SofWave SystemSofwave Medical, Ltd.20242—
+9K250146SofWave SystemSofwave Medical, Ltd.20251—
+10K251746Pure ImpactSofwave Medical, Ltd.20250—