510(k) Report

Devices descending from K000811

771 later devices reach Nlite System, SLS Model Number A00-1025 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+4K171227StarWalkerFotona D.O.O.20177—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K153229SuperbiumBios S.R.L.20162—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152012EVO platformQuanta System Spa201537—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+4K093168Mediflash and EsteflashDermeo20100—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K253765Vanish ProDdc Technologies, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—