510(k) Report

Devices descending from K023543

345 later devices reach Evlt Kit and D15PLUS and D30PLUS Diode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192856MT OneM&T S.R.L.20202—
+7K193486Epic 980Biolase, Inc.20202—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K172771Epic Pro 940Biolase, Inc.20171—
+7K172413MT ONEM&T S.R.L.20175—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+8K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+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—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K260138LUNE PureHygieneEnamel Pure20260—
+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—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+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—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—