510(k) Report

Devices descending from K000944

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K150724SculpSureCynosure, Inc.201521—
+7K150230SculpSureCynosure, Inc.201521—
+7K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K131839DC 7Dc International, LLC20130—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K111689StlaseDental Photonics, Inc.201222—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+8K254185Potenza PrimeJeisys Medical Incorporated20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+8K253803MILAN SystemLumenis Be, Ltd.20260—
+8K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+8K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+8K251254Ignite RF SystemInMode, Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+8K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+8K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+8K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+8K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252367InbellaMulti SystemInbella Medical, Inc.20250—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+8K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+8K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+8K243587PureLift GLOWXtreem Pulse, LLC20251—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243330LYMA Laser PROLyma Life, Ltd.20250—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K233642InMode RF SystemInMode, Ltd.20244—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K230167BACK 4Swims America Corp20230—
+8K230037BACK 3Swims America Corp20230—
+8K223805AgnesAgnes Medical Co., Ltd.20233—
+8K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K223110truSculpt iDCutera, Inc.20221—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—