510(k) Report

Devices descending from K043046

321 later devices reach Cooltouch, Model CT3S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K131839DC 7Dc International, LLC20130—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K22079410PLTentech Co., Ltd.20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K210084SilkroHironic Co., Ltd.20223—
+7K202041Opera EvoQuanta System Spa20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K153229SuperbiumBios S.R.L.20162—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K233123SilkroHironic Co., Ltd.20241—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K230077LaserMENeauvia North America20232—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K193426Elite iQCynosure, LLC20201—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—