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
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K023734Aramis II Dermatological LaserQuantel Medical2003317—
+1K022466Profile 1320 Laser SystemSciton, Inc2002520—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+1K020021Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Laserscope2002740—
+1K013825Candela Smoothbeam Laser SystemCandela Corp.20027401
+2K252561BTL-754FFBTL Industries, Inc.20260—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+2K110370Q-ClearLight Age, Inc.201135—
+2K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K041242Candela Smoothbeam Laser SystemCandela Corp.2004229—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+2K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+2K032459Profile 1320 Laser SystemSciton, Inc2004518—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+2K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+2K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K030510Depilase Twin Yag Laser SystemDepilase Group, Ltd.20030—
+2K030506Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20030—
+2K022951Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp.2003657—
+2K022884Candela Smoothbeam Laser SystemCandela Corp.20036421
+3K254271CAPRIORO Co., Ltd.20260—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K213461AviClear Laser SystemCutera, Inc.20222—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173676A-FITHironic Co., Ltd.20181—
+3K181510Echolaser X4El.En Electronic Engineering Spa20183—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141555AdvantageLutronic Corporation201414—
+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—
+3K132976AdvatxAdvalight Aps20141—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K122493GenesisplusCutera, Inc.201318—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K113115Epicare YagLight Age, Inc.20120—
+3K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111483Joule Clearsense Laser SystemSciton, Inc20110—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K090762LEDAQuantel Derma GmbH200946—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K030834Candela Smoothbeam Laser SystemCandela Corp.20036031
+3K030846Candela Smoothbeam Laser SystemCandela Corp.20033171
+3K030453Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc.2003524—
+4K260632Laser Thermal Therapy KitElesta S.P.A20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K250189AdvaTxAdvalight Aps20250—
+4K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K242207Noable LaserDaeju Meditech Engineering Co., Ltd.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—