510(k) Report

Devices descending from K013748

699 later devices reach Candela Sclero Long Pulse Laser (Aka Vbeam) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151337StrialiteCentre Light Solutions, LLC20160—
+1K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+1K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+2K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+2K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+2K110370Q-ClearLight Age, Inc.201135—
+2K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+2K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+2K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+2K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+2K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+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—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K250165PastelleWontech Co., Ltd.20250—
+3K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+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—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+3K141555AdvantageLutronic Corporation201414—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+3K133364Picosure WorkstationCynosure, Inc.201451—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+3K122493GenesisplusCutera, Inc.201318—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K121346Picosure WorkstationCynosure, Inc.201287—
+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—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+4K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+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—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K232236EchoQuanta System Spa20230—
+4K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K193266MIINMedico USA, Inc.20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K201406PicowonWontech Co., Ltd.20200—
+4K192856MT OneM&T S.R.L.20202—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K180593Vbeam Prima Laser SystemSyneron-Candela20182—