510(k) Report

Devices descending from K072849

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K250852CoolfaseAsterasys Co., Ltd.20250—
+3K251327XERFLutronic Corporation202501
+3K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+3K242241SunnyShenB Co., Ltd.20250—
+3K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+3K242688Finiff SystemSkingrab Co., Ltd.20240—
+3K240248Volnewmer™Classys, Inc.20241—
+3K23299210THERMATentech, Inc.20230—
+3K230663DensityJeisys Medical, Inc.20232—
+3K221989The OligioWontech Co., Ltd.20222—
+4K253504Volnewmer™Classys, Inc.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+5K243929Oligio XWontech Co., Ltd.20250—