510(k) Report

Devices descending from K212866

7 later devices reach truSculpt flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251594truFlexSyrma Johari Medtech Limited20250—
+1K240347PTG-05Zimmer Medizinsysteme GmbH20240—
+1K232455SofWave SystemSofwave Medical, Ltd.20234—
+2K240687SofWave SystemSofwave Medical, Ltd.20243—
+3K241685SofWave SystemSofwave Medical, Ltd.20242—
+4K250146SofWave SystemSofwave Medical, Ltd.20251—
+5K251746Pure ImpactSofwave Medical, Ltd.20250—