510(k) Report

Devices descending from K090580

19 later devices reach Thermage Thermacool NXT System and Accessories through their predicates, nearest generation first.

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