510(k) Report

Devices descending from K953074

407 later devices reach Modified Luxar LX-20 Family CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123037LightscalpelLightscalpel, LLC20124—
+1K121580Surelase CO2 Laser SystemClinicon Corp.20120—
+1K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+1K042439Azuryt Model CLT 1401, CO2 Surgical Laser SystemDiamond Age Systems, Inc.20041—
+1K971821Unica 315 M CO2 Surgical Laser SystemReliant Technologies, Inc.19970—
+1K960475Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp.1996403—
+2K141658Light ScalpelLightscalpel, LLC20142—
+2K132661LightscalpelLightscalpel, LLC20143—
+2K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+2K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+2K081612Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical LasersAesculight, LLC20085—
+2K062248Azuryt Model CTL 1401, CO2 Surgical Laser SystemNorth American Clinical Lasers, Ltd.20060—
+2K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+2K014236Clinicon Waveguide Platform with Interconnect for Luxar AccessoriesClinicon Corp.20020—
+2K992472Sureguide CO2 Laser Beam Delivery SystemClinicon Corp.199917—
+2K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc.1999377—
+2K971539Novatip Family of Laser Handpiece TipsXanova Corp.19972—
+3K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+3K173827LightScalpelLightscalpel, LLC20180—
+3K121471Lightscalpel Family of Handpiece Tips for CO2 Surgical LasersLightscalpel, LLC20124—
+3K112166Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering20111—
+3K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K070071Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc.20070—
+3K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc.20062—
+3K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc.200514—
+3K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+3K014048Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp.200215—
+3K993942Litesaber 2000Laser Dental Innovations20001—
+4K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+4K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering20210—
+4K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K091115ECO2 Laser SystemLutronic Corporation200927—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.200815—
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc.20085—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S20070—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc.200781
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K063141Omniguide Zero Flow ZF-T 150 Waveguide FiberOmniguide, Inc.20061—
+4K062423Omniguide Beampath Laser Beam Delivery SystemOmniguide, Inc.20061—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+4K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+4K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.200416—
+4K031795Reliant Laser SystemReliant Technologies, Inc.2003318—
+4K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+4K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003323—
+5K244060eCO2 3DLutronic Corporation20250—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K203241OmniGuide BeamPath OTO-U FiberOmniguide, Inc.20210—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+5K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+5K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K120932Opelaser Pro II and the Opelaser Lite IIThe Yoshida Dental Mfg. Co., Ltd.20120—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K102461FractoraInvasix, Ltd.201124—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+5K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc.20094—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K082809Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc.200812—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+5K073409Omniguide Sterile Waveguide Adapter SystemOmniguide, Inc.20070—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K052936Thermage Thermacool SystemThermage, Inc.2007103—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—