510(k) Report

Devices descending from K040921

204 later devices reach Cooltouch, Model NS 160 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202041Opera EvoQuanta System Spa20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152714Quanta ForteQuanta System Spa201513—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K232106Air Gap FiberWontech Co., Ltd.20240—
+7K232236EchoQuanta System Spa20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K192856MT OneM&T S.R.L.20202—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K172413MT ONEM&T S.R.L.20175—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+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—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—