510(k) Report

Devices descending from K003183

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+10K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+10K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+10K243737Inbella RF SystemInbella Medical, Inc.20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233224Epilaser ProEpilady 2000, LLC20240—
+10K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K230467BTL-899FBTL Industries, Inc.20231—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+10K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+10K192970SlimusHironic Co., Ltd.20200—
+10K200693K2 MobileHulaser, Inc.20202—
+10K202041Opera EvoQuanta System Spa20200—
+10K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+10K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+10K193486Epic 980Biolase, Inc.20202—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K191086ExciplexClarteis20194—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K180044SIROLaser BlueDentsply Sirona201812—
+10K173677InMode VLazeInmode MD, Ltd.20183—
+10K171992SculpSureCynosure, Inc.20178—
+10K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+10K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+10K163128Epic ProBiolase, Inc.201716—
+10K163222Discovery Pico FamilyQuanta System Spa201630—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+11K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+11K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+11K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+11K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+11K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+11K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+11K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K240752Deka ToroEl.En S.P.A.20240—
+11K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+11K234085LUNE™ PureHygieneEnamel Pure20241—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—