510(k) Report

Devices descending from K170758

13 later devices reach Thermage FLX System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250852CoolfaseAsterasys Co., Ltd.20250—
+1K251327XERFLutronic Corporation202501
+1K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+1K242688Finiff SystemSkingrab Co., Ltd.20240—
+1K240248Volnewmer™Classys, Inc.20241—
+1K23299210THERMATentech, Inc.20230—
+1K230663DensityJeisys Medical, Inc.20232—
+1K221989The OligioWontech Co., Ltd.20222—
+2K253504Volnewmer™Classys, Inc.20260—
+2K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+2K240897CellinewVIOL Co., Ltd.20240—
+2K240313Oligio XWontech Co., Ltd.20241—
+3K243929Oligio XWontech Co., Ltd.20250—