510(k) Report

Devices descending from K061618

234 later devices reach Cooltouch, Model Ctev through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+1K08222515W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc.2008128—
+1K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+2K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K160549Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20176—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+2K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+2K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+2K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+2K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+2K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+2K110225Angiodynamics, Inc. Venacure 1470 LaserAngioDynamics, Inc.20110—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+2K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+3K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K241930VeincareWontech Co., Ltd.20241—
+3K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K211977Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd.20213—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+3K173285Joule SystemSciton, Inc20185—
+3K171227StarWalkerFotona D.O.O.20177—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+3K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K133774AtovenBio-Med USA, Inc.20146—
+3K132976AdvatxAdvalight Aps20141—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K252564Medical Diode Laser Systems (VeinCure)Baoding Te'Anzhou Electronic Technology Co., Ltd.20250—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K251288VeincareWontech Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K231548Medical Diode Laser, Model S1ProWuhan Pioon Technology Co., Ltd.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K202172StarWalkerFotona D.O.O.20203—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—