510(k) Report

Devices descending from K030834

603 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K253123CuRAS hybridClassys, Inc.20250—
+7K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+7K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K244060eCO2 3DLutronic Corporation20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K232236EchoQuanta System Spa20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+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—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K193426Elite iQCynosure, LLC20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—