510(k) Report

Devices descending from K061618

234 later devices reach Cooltouch, Model Ctev through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+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—
+8K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+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—