510(k) Report

Devices descending from K983984

520 later devices reach Cooltouch V ND:Yag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K142093V20 SystemViora, Ltd.201432—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140120EPIC 10Biolase, Inc.20141—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K232236EchoQuanta System Spa20230—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230077LaserMENeauvia North America20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K193266MIINMedico USA, Inc.20210—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—