510(k) Report

Devices descending from K973354

222 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—
+1K990119Epi-Star Surgical Laser SysterNidek, Inc.200050—
+1K984601Candela Gentlelase II Dermatological LaserCandela Corp.1999110—
+1K983977Light Age Epicare Alexandrite LaserLight Age, Inc.1999118—
+1K982316Laseaway Alexandrite Laser SystemSilver Creek, Inc.19981—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+2K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+2K013864Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc.200249—
+2K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+2K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc.19990—
+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—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+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
+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—
+4K152714Quanta ForteQuanta System Spa201513—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+4K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+4K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+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—
+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—
+5K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+5K241656Eneka SelectifTermosalud20241—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232236EchoQuanta System Spa20230—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K192856MT OneM&T S.R.L.20202—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172413MT ONEM&T S.R.L.20175—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—