510(k) Report

Devices descending from K994260

258 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+1K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+1K042474ARIONWavelight Laser Technologie AG2004114—
+1K041262Duralite-GLLaser Scientific20040—
+1K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+1K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+1K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+1K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+1K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+1K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+1K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+2K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+2K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+2K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+2K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K063074Candela 3630 Laser SystemCandela Corp.2006179—
+2K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+2K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+3K173285Joule SystemSciton, Inc20185—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132976AdvatxAdvalight Aps20141—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+3K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+3K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+3K130199Clarity LPC Laser SystemLutronic Corporation20135—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+3K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+3K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+3K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K250189AdvaTxAdvalight Aps20250—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K183566CLARITY II Laser SystemLutronic Corporation201911
+4K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+4K181510Echolaser X4El.En Electronic Engineering Spa20183—
+4K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+4K180508Joule SystemSciton, Inc20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152012EVO platformQuanta System Spa201537—
+4K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+4K141555AdvantageLutronic Corporation201414—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K113115Epicare YagLight Age, Inc.20120—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K260632Laser Thermal Therapy KitElesta S.P.A20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+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—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+5K232236EchoQuanta System Spa20230—