510(k) Report

Devices descending from K003715

763 later devices reach Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K223727LavieenWontech Co., Ltd.20234—
+7K230077LaserMENeauvia North America20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K221873NeoGen PSR SystemEnergist Limited20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193266MIINMedico USA, Inc.20210—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K193201BTL-785FBtl20208—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K193426Elite iQCynosure, LLC20201—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K180224Element-TLElemenic Co., Ltd.20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+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—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K131839DC 7Dc International, LLC20130—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K253123CuRAS hybridClassys, Inc.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+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—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—