510(k) Report

Devices descending from K024335

187 later devices reach Candela Gentlelase Family of Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+1K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+1K063074Candela 3630 Laser SystemCandela Corp.2006179—
+1K042474ARIONWavelight Laser Technologie AG2004114—
+1K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+1K041262Duralite-GLLaser Scientific20040—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+2K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+2K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+2K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K173285Joule SystemSciton, Inc20185—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+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—
+3K113115Epicare YagLight Age, Inc.20120—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K22079410PLTentech Co., Ltd.20220—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K200616E>EyeCE-Swin20200—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K193656SkyPulseFotona D.O.O.202011—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K183566CLARITY II Laser SystemLutronic Corporation201911
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+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—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+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—
+4K132976AdvatxAdvalight Aps20141—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+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—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211