510(k) Report

Devices descending from K970934

304 later devices reach CB Erbium/2.94(TM) ER:Yag Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172413MT ONEM&T S.R.L.20175—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K140120EPIC 10Biolase, Inc.20141—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K131839DC 7Dc International, LLC20130—
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K202041Opera EvoQuanta System Spa20200—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+10K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+10K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+11K232106Air Gap FiberWontech Co., Ltd.20240—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—