510(k) Report

Devices descending from K941841

1,178 later devices reach Smartscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+1K974633Scantech Laser ScannerPhantom Technologies, Inc.19980—
+1K960032Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group19961,152—
+2K161503ORIONYerim Engineering Co., Ltd.20161—
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+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—
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K980389Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc.19983—
+2K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970—
+2K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.19971,142—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K180224Element-TLElemenic Co., Ltd.20180—
+3K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+3K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K110370Q-ClearLight Age, Inc.201135—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.20061—
+3K060905Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp20060—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+3K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+3K001589Candela Dynamic Cooling DeviceCandela Corp.20001,064—
+3K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+4K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162851eLyx-PROIntelligent Sensory Concept SA20170—
+4K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K141555AdvantageLutronic Corporation201414—
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461