510(k) Report

Devices descending from K080121

196 later devices reach Cynosure Smartlipo Multiwavlength Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+4K131839DC 7Dc International, LLC20130—
+4K130465EPIC 10SBiolase Technology, Inc.20130—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K251730LIA Console (542-7)Leadoptik, Inc.20250—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202041Opera EvoQuanta System Spa20200—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K152714Quanta ForteQuanta System Spa201513—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232236EchoQuanta System Spa20230—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K192856MT OneM&T S.R.L.20202—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K172413MT ONEM&T S.R.L.20175—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232106Air Gap FiberWontech Co., Ltd.20240—
+7K22079410PLTentech Co., Ltd.20220—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—