510(k) Report

Devices descending from K043402

124 later devices reach Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+1K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+1K052936Thermage Thermacool SystemThermage, Inc.2007103—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+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—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+3K102461FractoraInvasix, Ltd.201124—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K253504Volnewmer™Classys, Inc.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K193201BTL-785FBtl20208—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K210084SilkroHironic Co., Ltd.20223—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K233123SilkroHironic Co., Ltd.20241—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—