510(k) Report

Devices descending from K982546

480 later devices reach Phaser-2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC20121—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K070690The Life VesselCottonwood Vessel Corporation20070—
+1K043317Omnilux PlusPhoto Therapeutics Limited2005171—
+1K042813Biobeam Narrow Band Light Therapy DevicesLife Without Pain, LLC200522—
+1K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315—
+1K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc.2003198—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K162851eLyx-PROIntelligent Sensory Concept SA20170—
+2K153229SuperbiumBios S.R.L.20162—
+2K150716Varaya SportVaraya Photoceuticals, LLC20150—
+2K141237Harmony LiteAlma, Inc.20154—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K120460SmartluxMedmix Co., Ltd.201218—
+2K110558CS1000 Light Therapy DeviceGenesis Health Light Corporation20120—
+2K120582HeatluxHome Skinovations, Ltd.20123—
+2K113668Healite II SystemLutronic Corporation20120—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K113231WARP10,WARP75Quantum Devices, Inc.20120—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101716HVR Pain Relief DeviceH.V.R., Inc.20115—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+2K090008Tanda Restore, Model PtscsPharos Life Corporation20096—
+2K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+2K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC200915—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K073681Nanobeam 940, Model 940-900-02Davaray, Inc.20080—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K073000LumaprobeClareblend, Inc.20080—
+2K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K080084Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC20081—
+2K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+2K072048Lumacare Model LC-122M Non-Coherent Light Source and Model Lum-P Fibre Optic ProbeLynton Lasers Limited20070—
+2K062635MODEL 2200Clarimedex, Inc.20060—
+2K060792IllumimedPhotoactif, LLC2006115—
+2K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+2K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+2K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+2K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+2K043055Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc.200519—
+2K051046Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC200503
+2K042532Biocare Systems Premir 818Biocare Systems, Inc.20048—
+2K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213524CytonPro-5000Cytonsys, Inc.20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K203054FlexSysGme German Medical Engineering GmbH20210—
+3K200616E>EyeCE-Swin20200—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+3K191693BC-5Reveallux, Corp20190—
+3K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172413MT ONEM&T S.R.L.20175—
+3K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162763Vevazz LED Heat LampVevazz, LLC20170—
+3K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+3K152280BioPhotas Celluma3Biophotas, Inc.201649—
+3K152714Quanta ForteQuanta System Spa201513—
+3K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+3K150466ZX2 Laser SystemLzr7, Inc.20150—
+3K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+3K150175HeatLux Pro IHome Skinovations, Ltd.20151—
+3K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K122237Biophotas LifelightBiophotas, Inc.201371—
+3K111286Quasar CalypsoSilver Bay, LLC201276—