510(k) Report

Devices descending from K993671

700 later devices reach Candela Sclero Long Pulse Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+2K151337StrialiteCentre Light Solutions, LLC20160—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K110370Q-ClearLight Age, Inc.201135—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+3K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+3K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+3K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+3K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K023881Profile 1064 Laser SystemSciton, Inc2003227—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K193656SkyPulseFotona D.O.O.202011—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K141555AdvantageLutronic Corporation201414—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K122493GenesisplusCutera, Inc.201318—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063828Diomed Delta 25Diomed, Ltd.20075—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+4K040384Mydon CWavelight Laser Technologie AG200451—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K250189AdvaTxAdvalight Aps20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K232236EchoQuanta System Spa20230—
+5K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K193266MIINMedico USA, Inc.20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K201406PicowonWontech Co., Ltd.20200—
+5K192856MT OneM&T S.R.L.20202—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—