510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998811—
+1K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp.19971,1791
+1K971874Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc.1997816—
+2K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+2K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+2K042474ARIONWavelight Laser Technologie AG2004114—
+2K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+2K990119Epi-Star Surgical Laser SysterNidek, Inc.200050—
+2K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+2K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical2000745—
+2K984601Candela Gentlelase II Dermatological LaserCandela Corp.1999110—
+2K983977Light Age Epicare Alexandrite LaserLight Age, Inc.1999118—
+2K982316Laseaway Alexandrite Laser SystemSilver Creek, Inc.19981—
+2K974381Candela Gentlelase GL Dermatological LaserCandela Corp.19981,178—
+2K973354Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc.1997222—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K041262Duralite-GLLaser Scientific20040—
+3K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+3K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+3K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K023881Profile 1064 Laser SystemSciton, Inc2003227—
+3K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+3K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+3K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+3K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+3K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+3K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+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—
+3K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+3K013864Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc.200249—
+3K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+3K990417DermacoolOptomed Corp.19991,062—
+3K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc.19990—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K173285Joule SystemSciton, Inc20185—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+4K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K113115Epicare YagLight Age, Inc.20120—
+4K110370Q-ClearLight Age, Inc.201135—
+4K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+4K063828Diomed Delta 25Diomed, Ltd.20075—
+4K063074Candela 3630 Laser SystemCandela Corp.2006179—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+4K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+4K040384Mydon CWavelight Laser Technologie AG200451—
+4K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+4K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+4K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+4K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+4K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+4K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+4K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+4K014253Dermachiller 4Paradigm Trex, LLC200250—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K183566CLARITY II Laser SystemLutronic Corporation201911
+5K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180508Joule SystemSciton, Inc20183—