510(k) Report

Devices descending from K974381

1,178 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+1K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+1K990417DermacoolOptomed Corp.19991,062—
+1K984601Candela Gentlelase II Dermatological LaserCandela Corp.1999110—
+1K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998811—
+2K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K042474ARIONWavelight Laser Technologie AG2004114—
+2K041262Duralite-GLLaser Scientific20040—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+2K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+2K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+2K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+2K014253Dermachiller 4Paradigm Trex, LLC200250—
+2K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+2K990119Epi-Star Surgical Laser SysterNidek, Inc.200050—
+2K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+2K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical2000745—
+3K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+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—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+3K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+3K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+3K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+3K023881Profile 1064 Laser SystemSciton, Inc2003227—
+3K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+3K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+3K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd.2002229—
+3K020463Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20021—
+3K013864Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc.200249—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K183566CLARITY II Laser SystemLutronic Corporation201911
+4K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+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—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162851eLyx-PROIntelligent Sensory Concept SA20170—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+4K141237Harmony LiteAlma, Inc.20154—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+4K141555AdvantageLutronic Corporation201414—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—