510(k) Report

Devices descending from K021402

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+9K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+9K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K233766Geneo X ElitePollogen, Ltd.20240—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K213344BTL-899ABTL Industries, Inc.20222—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K192970SlimusHironic Co., Ltd.20200—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K193486Epic 980Biolase, Inc.20202—
+9K193426Elite iQCynosure, LLC20201—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K191086ExciplexClarteis20194—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K171992SculpSureCynosure, Inc.20178—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+9K163128Epic ProBiolase, Inc.201716—
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K160368EVO platformQuanta System Spa201636—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152012EVO platformQuanta System Spa201537—
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—