510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211605Dual SwitchLaser Engineering, Inc.20220—
+1K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+1K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+1K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998653—
+1K974633Scantech Laser ScannerPhantom Technologies, Inc.19980—
+1K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970—
+1K971821Unica 315 M CO2 Surgical Laser SystemReliant Technologies, Inc.19970—
+1K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997675—
+1K960032Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group19961,152—
+2K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+2K101321Ematrix CO2Syneron Medical, Ltd.20102—
+2K091115ECO2 Laser SystemLutronic Corporation200927—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.200815—
+2K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+2K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+2K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+2K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S20070—
+2K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K063001Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L.200763—
+2K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+2K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+2K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+2K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.200416—
+2K031795Reliant Laser SystemReliant Technologies, Inc.2003318—
+2K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+2K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003323—
+2K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+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—
+2K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.19971,142—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K151655CO2RE SystemSyneron Medical, Ltd.20151—
+3K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+3K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+3K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+3K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+3K122200A3F FrationalPollogen, Ltd.20130—
+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—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K102461FractoraInvasix, Ltd.201124—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+3K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+3K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+3K101555CO2 Laser SystemAdvanced Technology Laser Co., Ltd.201016—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+3K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+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—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+3K080932Mosaic Laser SystemLutronic Corporation20086—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+3K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+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—
+3K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K050412VapormaxTrimedyne, Inc.20052—
+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—