510(k) Report

Devices descending from K922901

320 later devices reach Incisor I Pulsed ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+8K171227StarWalkerFotona D.O.O.20177—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K152714Quanta ForteQuanta System Spa201513—
+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—
+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—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K252561BTL-754FFBTL Industries, Inc.20260—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K241656Eneka SelectifTermosalud20241—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K234057NirvanaEl.En S.P.A.20240—
+9K233024Alma HarmonyAlma Lasers, Inc.20241—
+9K232236EchoQuanta System Spa20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K221571InMode Multi-systemInMode, Ltd.20222—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K202288FinebeamSNJ Co., Ltd.20212—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K202172StarWalkerFotona D.O.O.20203—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K192856MT OneM&T S.R.L.20202—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+9K191942MT One DiamondM&T S.R.L.20191—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K172413MT ONEM&T S.R.L.20175—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+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—
+10K252723Dynamis Pro FamilyFotona D.O.O.20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K253342PICO-KSpeclipse, Inc.20251—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K251632Optimas MAX SystemInMode, Ltd.20251—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K22079410PLTentech Co., Ltd.20220—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K212790XLase PlusBiotec Italia, Srl20220—
+10K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K202041Opera EvoQuanta System Spa20200—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—
+10K200616E>EyeCE-Swin20200—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+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
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K252215InbellaMAX SystemInbella Medical, Ltd.20250—