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
+6K213261EpilMENeauvia North America20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+6K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K152012EVO platformQuanta System Spa201537—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K083008CoolskinElbio Co., Ltd.20092—
+6K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+6K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+6K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+6K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+6K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K080735CryominiZimmer Elektromedizin GmbH20081—
+6K072344Apl Medical SystemBios S.R.L.20076—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+6K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+6K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K052354Oculase MDBiolase Technology, Inc.20065—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—