510(k) Report

Devices descending from K014040

739 later devices reach Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K193426Elite iQCynosure, LLC20201—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K182173Joule SystemSciton, Inc20195—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+8K253123CuRAS hybridClassys, Inc.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K244060eCO2 3DLutronic Corporation20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K223727LavieenWontech Co., Ltd.20234—
+8K230077LaserMENeauvia North America20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K202041Opera EvoQuanta System Spa20200—
+8K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—