510(k) Report

Devices descending from K051710

56 later devices reach Thermage Thermacool Coupling Fluid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+1K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+1K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+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—
+3K090094Zeltiq SystemZeltiq Aesthetics200932—
+4K253504Volnewmer™Classys, Inc.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+5K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+5K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+6K160470SculpSureCynosure, Inc.201620—
+6K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+6K150724SculpSureCynosure, Inc.201521—
+6K150230SculpSureCynosure, Inc.201521—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K171111SculpsureCynosure, Inc.201710—
+7K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K192970SlimusHironic Co., Ltd.20200—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K171992SculpSureCynosure, Inc.20178—
+8K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K182741SculpSureCynosure20195—
+9K172144CoolSculpting SystemZeltiq Aesthetics20177—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+10K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805