510(k) Report

Devices descending from K933804

803 later devices reach Lectron II Conductive Gel/Cadwell Electrode Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K241656Eneka SelectifTermosalud20241—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K233123SilkroHironic Co., Ltd.20241—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K232236EchoQuanta System Spa20230—
+9K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+9K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+9K223292TempSure SystemCynosure, LLC20220—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K223110truSculpt iDCutera, Inc.20221—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K211107BTL-899 FPBTL Industries, Inc.20213—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K193266MIINMedico USA, Inc.20210—
+9K202172StarWalkerFotona D.O.O.20203—
+9K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+9K201406PicowonWontech Co., Ltd.20200—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K192430Epic 980Biolase, Inc.20195—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+9K183156V-LaserWontech Co., Ltd.20193—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+9K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+9K180406Ellipse YdunEllipse A/S20180—
+9K173199PicoSure WorkstationCynosure, Inc.20189—
+9K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+9K171702Exciplex308nmClarteis20175—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K171111SculpsureCynosure, Inc.201710—
+9K162755PicocareWontech Co., Ltd.20179—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+9K152856Helios IIILaseroptek Co., Ltd.20165—
+9K160480PicoSure WorkstationCynosure, Inc.201620—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K150326PicoWay Laser SystemCandela Corporation201568—
+9K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—