510(k) Report

Devices descending from K944090

1,155 later devices reach Candela Alex Lazr Q-Switched Alexandrite Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K213261EpilMENeauvia North America20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+7K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+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—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+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—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K191086ExciplexClarteis20194—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K182173Joule SystemSciton, Inc20195—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+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—
+7K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+7K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K170850Alma QAlma Lasers, Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+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—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—