510(k) Report

Devices descending from K971874

816 later devices reach Sharplan Epitouch Alexandrite Laser System (5000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+1K042474ARIONWavelight Laser Technologie AG2004114—
+1K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+1K983977Light Age Epicare Alexandrite LaserLight Age, Inc.1999118—
+1K982316Laseaway Alexandrite Laser SystemSilver Creek, Inc.19981—
+1K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998811—
+1K973354Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc.1997222—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+2K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K990119Epi-Star Surgical Laser SysterNidek, Inc.200050—
+2K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+2K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical2000745—
+2K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc.19990—
+2K984601Candela Gentlelase II Dermatological LaserCandela Corp.1999110—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K173285Joule SystemSciton, Inc20185—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K113115Epicare YagLight Age, Inc.20120—
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+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—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K180508Joule SystemSciton, Inc20183—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K152714Quanta ForteQuanta System Spa201513—
+4K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+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—
+4K110370Q-ClearLight Age, Inc.201135—
+4K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+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—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—