510(k) Report

Devices descending from K033172

654 later devices reach Candela Gentleyag Family of Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K221761SoleaConvergent Dental, Inc.202201
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K213261EpilMENeauvia North America20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K213428EdgeProBiolase, Inc.20210—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K212082PicoreBio-Med USA, Inc.20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K193266MIINMedico USA, Inc.20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+5K193201BTL-785FBtl20208—
+5K201406PicowonWontech Co., Ltd.20200—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193426Elite iQCynosure, LLC20201—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K182173Joule SystemSciton, Inc20195—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K182669Youlaser CO2Quanta System Spa20181—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K150664NeoLasSheaumann Laser, Inc.20151—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150027CYMAWhitecap Technologies, LLC20150—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—