510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K192331LaseMD LEO Laser SystemLutronic Global20190—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K182173Joule SystemSciton, Inc20195—
+9K182669Youlaser CO2Quanta System Spa20181—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K173199PicoSure WorkstationCynosure, Inc.20189—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+9K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K172096FraxisIlooda Co,., Ltd.20172—
+9K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+9K171009LASEMD Laser SystemLutronic Corporation20178—
+9K170325Secret RFIlooda Co,., Ltd.201710—
+9K162755PicocareWontech Co., Ltd.20179—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+9K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+9K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+9K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+9K152856Helios IIILaseroptek Co., Ltd.20165—
+9K160480PicoSure WorkstationCynosure, Inc.201620—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K150326PicoWay Laser SystemCandela Corporation201568—
+9K150027CYMAWhitecap Technologies, LLC20150—
+9K143105Picosure WorkstationCynosure, Inc.201549—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K142372Pico Way Laser SystemCandela Corpation201470—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K140719Picosure WorkstationCynosure, Inc.201450—
+9K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+9K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+9K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K253123CuRAS hybridClassys, Inc.20250—
+10K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K244060eCO2 3DLutronic Corporation20250—
+10K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+10K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K223727LavieenWontech Co., Ltd.20234—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K222685NIRA Model 2Dermal Photonics Corp20230—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+10K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K212663Helios IV 785Laseroptek Co., Ltd.20223—
+10K210084SilkroHironic Co., Ltd.20223—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K210226PicoSure WorkstationCynosure, LLC20213—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+10K200786Venus EpileveVenus Concept USA, Inc.20200—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K191685PicoWay Laser SystemCandela Corporation201920—
+10K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+10K182997enlighten III Laser SystemCutera, Inc.20180—
+10K181272Picocare FamilyWontech Co., Ltd.20188—
+10K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+10K160470SculpSureCynosure, Inc.201620—