510(k) Report

Devices descending from K013825

740 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041242Candela Smoothbeam Laser SystemCandela Corp.2004229—
+1K032459Profile 1320 Laser SystemSciton, Inc2004518—
+1K023734Aramis II Dermatological LaserQuantel Medical2003317—
+1K022884Candela Smoothbeam Laser SystemCandela Corp.20036421
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K254271CAPRIORO Co., Ltd.20260—
+2K252561BTL-754FFBTL Industries, Inc.20260—
+2K213461AviClear Laser SystemCutera, Inc.20222—
+2K173676A-FITHironic Co., Ltd.20181—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+2K110370Q-ClearLight Age, Inc.201135—
+2K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+2K030834Candela Smoothbeam Laser SystemCandela Corp.20036031
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K030846Candela Smoothbeam Laser SystemCandela Corp.20033171
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+2K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K030453Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc.2003524—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K242207Noable LaserDaeju Meditech Engineering Co., Ltd.20250—
+3K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+3K230660AviClear Laser SystemCutera, Inc.20231—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K141555AdvantageLutronic Corporation201414—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K122493GenesisplusCutera, Inc.201318—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+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—
+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—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc.2004569—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251149AviClear Laser SystemCutera, Inc.20250—
+4K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K232236EchoQuanta System Spa20230—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—