510(k) Report

Devices descending from K053365

203 later devices reach Modification to Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243737Inbella RF SystemInbella Medical, Inc.20250—
+9K230467BTL-899FBTL Industries, Inc.20231—
+9K223292TempSure SystemCynosure, LLC20220—