510(k) Report

Devices descending from K990718

745 later devices reach Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K193266MIINMedico USA, Inc.20210—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K193201BTL-785FBtl20208—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K193426Elite iQCynosure, LLC20201—
+8K192331LaseMD LEO Laser SystemLutronic Global20190—
+8K182173Joule SystemSciton, Inc20195—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K171009LASEMD Laser SystemLutronic Corporation20178—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K160312Fraxis DuoIlooda Co,., Ltd.201614—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+8K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K244060eCO2 3DLutronic Corporation20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241270BTL-754BTL Industries, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K223727LavieenWontech Co., Ltd.20234—
+9K230077LaserMENeauvia North America20232—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—