510(k) Report

Devices descending from K961971

339 later devices reach Q-5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K152714Quanta ForteQuanta System Spa201513—
+8K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+8K140120EPIC 10Biolase, Inc.20141—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+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—
+8K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+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—
+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—
+9K252561BTL-754FFBTL Industries, Inc.20260—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+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—
+9K231126Eblator DeviceE Surgical, LLC20231—
+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—
+9K212055Connected OR Hub with Device and Voice ControlStryker Corporation20216—
+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—
+9K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlStryker20208—
+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—
+9K192172Connected OR Hub with Device and Voice ControlStryker20199—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+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—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+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—
+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—
+10K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+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—
+10K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+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—
+10K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Endoscopy20224—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K212790XLase PlusBiotec Italia, Srl20220—