510(k) Report

Devices descending from K032088

131 later devices reach Modification to Thermacool TC System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+1K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+1K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+2K060948Portrait PSR3Rhytec Incorporated20061101
+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—
+3K071786Portrait PSRRhytec Incorporated2007109—
+4K253504Volnewmer™Classys, Inc.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K072394Portrait Stand-OffRhytec Incorporated2007104—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K221873NeoGen PSR SystemEnergist Limited20230—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K132754Neogen PSR SystemEnergist, Ltd.20132—
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K102461FractoraInvasix, Ltd.201124—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K131758Surgen UPollogen, Ltd.20135—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K193201BTL-785FBtl20208—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K160312Fraxis DuoIlooda Co,., Ltd.201614—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K172096FraxisIlooda Co,., Ltd.20172—
+9K170325Secret RFIlooda Co,., Ltd.201710—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K210084SilkroHironic Co., Ltd.20223—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K203728DarwinLuvo Medical Technologies, Inc.20211—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+10K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K250281Deka LotusEl.En S.P.A.20250—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K233123SilkroHironic Co., Ltd.20241—