510(k) Report

Devices descending from K233996

3 later devices reach Ulthera System (UC-1 Control Unit PRIME) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc.20251—
+1K243035Ulthera® SystemUlthera, Inc.20252—
+2K260618Ulthera® SystemUlthera, Inc.20260—