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
+1K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+1K024189Nlite System, Model#: A00-1025/A00-1033Icn Photonics, Ltd.2003328—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+1K020021Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Laserscope2002740—
+1K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+1K013461Nlite System,Model A00-1025Icn Photonics, Ltd.2002711—
+1K013043Candela Clearbeam Pulsed Dye LaserCandela Corp.2001703—
+2K151337StrialiteCentre Light Solutions, LLC20160—
+2K132976AdvatxAdvalight Aps20141—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+2K110370Q-ClearLight Age, Inc.201135—
+2K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K050165Modification to Ifl Professional System, Model C100Cyden Limited200510—
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+2K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+2K033331Candela Cbeam Pulse Dye Laser SystemCandela Corp.2004230—
+2K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+2K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+2K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K030510Depilase Twin Yag Laser SystemDepilase Group, Ltd.20030—
+2K030506Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20030—
+2K022951Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp.2003657—
+2K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+2K020958Candela Cbeam Pulsed Dye Laser SystemCandela Corp.2002231—
+2K020729Nlite System,Model A00-1051Icn Photonics, Ltd.20023—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K250189AdvaTxAdvalight Aps20250—
+3K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K181510Echolaser X4El.En Electronic Engineering Spa20183—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141555AdvantageLutronic Corporation201414—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K122493GenesisplusCutera, Inc.201318—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K113115Epicare YagLight Age, Inc.20120—
+3K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111483Joule Clearsense Laser SystemSciton, Inc20110—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K090762LEDAQuantel Derma GmbH200946—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K090399Trios SystemViora, Ltd.20090—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+3K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K260632Laser Thermal Therapy KitElesta S.P.A20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K232236EchoQuanta System Spa20230—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K213594Echolaser X4Elesta S.P.A20221—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—