510(k) Report

Devices descending from K946304

1,420 later devices reach Coherent Family of CO2 Surgical Laser Scanner Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993146Dornier Scanner HandpieceDornier Surgical Products, Inc.19990—
+1K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998653—
+1K974633Scantech Laser ScannerPhantom Technologies, Inc.19980—
+1K970757Fotona SkinscanMedical Laser Solutions19971—
+1K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997675—
+1K960820Sharplan Lasers, Inc. Silktouch XJ ScannerSharplan Lasers, Inc.19961—
+1K960032Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group19961,152—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+2K063001Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L.200763—
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+2K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003323—
+2K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+2K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+2K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+2K020408System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage WandsffArthrocare Corp.20020—
+2K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc.1999350—
+2K980398Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd.19980—
+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—
+3K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+3K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+3K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+3K123573Youlaser CO2 LaserQuanta System Spa201319—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K120932Opelaser Pro II and the Opelaser Lite IIThe Yoshida Dental Mfg. Co., Ltd.20120—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101555CO2 Laser SystemAdvanced Technology Laser Co., Ltd.201016—
+3K091115ECO2 Laser SystemLutronic Corporation200927—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+3K083918Atl CO2 Medical Laser Systems, Models Atl-150 and Atl-250Advanced Technology Laser Co., Ltd.20090—
+3K082809Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc.200812—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.200815—
+3K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+3K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S20070—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+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—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K050412VapormaxTrimedyne, Inc.20052—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+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—
+3K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.200416—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K031795Reliant Laser SystemReliant Technologies, Inc.2003318—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, 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—
+3K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+3K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+3K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+3K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+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—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K211362SCAR 3El.En Electronic Engineering Spa20211—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20201—