510(k) Report

Devices descending from K030834

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041242Candela Smoothbeam Laser SystemCandela Corp.2004229—
+1K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc.2004569—
+2K254271CAPRIORO Co., Ltd.20260—
+2K213461AviClear Laser SystemCutera, Inc.20222—
+2K173676A-FITHironic Co., Ltd.20181—
+2K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K242207Noable LaserDaeju Meditech Engineering Co., Ltd.20250—
+3K230660AviClear Laser SystemCutera, Inc.20231—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+3K171227StarWalkerFotona D.O.O.20177—
+3K152012EVO platformQuanta System Spa201537—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+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—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+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—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K251149AviClear Laser SystemCutera, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+4K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161669Waterlase ExpressBiolase, Inc.201621—
+4K153229SuperbiumBios S.R.L.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K102461FractoraInvasix, Ltd.201124—