510(k) Report

Devices descending from K946304

1,420 later devices reach Coherent Family of CO2 Surgical Laser Scanner Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+7K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K202250Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20200—
+7K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd.20205—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192990Litho EvoQuanta System Spa20190—
+7K191086ExciplexClarteis20194—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+7K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+7K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+7K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+7K152611V20 systemViora, Ltd.20164—
+7K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+7K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+7K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+7K142289PK SpatulaGyrus Acmi, Inc.20141—
+7K141555AdvantageLutronic Corporation201414—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+7K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—