510(k) Report

Devices descending from K040131

569 later devices reach Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193426Elite iQCynosure, LLC20201—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—