510(k) Report

Devices descending from K000944

1,069 later devices reach Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212891TempSure SystemCynosure, LLC20221—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+8K211107BTL-899 FPBTL Industries, Inc.20213—
+8K210948Omnilux CLEARGlobalmed Technologies202139—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K193486Epic 980Biolase, Inc.20202—
+8K193426Elite iQCynosure, LLC20201—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180406Ellipse YdunEllipse A/S20180—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170709CURVE Laser SystemYolo Medical, Inc.20170—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K163128Epic ProBiolase, Inc.201716—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160470SculpSureCynosure, Inc.201620—
+8K160368EVO platformQuanta System Spa201636—
+8K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152012EVO platformQuanta System Spa201537—
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+9K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+9K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+9K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+9K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+9K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+9K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+9K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+9K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+9K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+9K240780InMode RF SystemInMode, Ltd.20243—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K233766Geneo X ElitePollogen, Ltd.20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+9K223292TempSure SystemCynosure, LLC20220—
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K213344BTL-899ABTL Industries, Inc.20222—
+9K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+9K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K201773PicohiHironic Co., Ltd.20215—