510(k) Report

Devices descending from K960475

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132661LightscalpelLightscalpel, LLC20143—
+1K081612Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical LasersAesculight, LLC20085—
+1K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+1K042439Azuryt Model CLT 1401, CO2 Surgical Laser SystemDiamond Age Systems, Inc.20041—
+1K014236Clinicon Waveguide Platform with Interconnect for Luxar AccessoriesClinicon Corp.20020—
+1K992472Sureguide CO2 Laser Beam Delivery SystemClinicon Corp.199917—
+1K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc.1999377—
+1K971539Novatip Family of Laser Handpiece TipsXanova Corp.19972—
+2K141658Light ScalpelLightscalpel, LLC20142—
+2K121471Lightscalpel Family of Handpiece Tips for CO2 Surgical LasersLightscalpel, LLC20124—
+2K112166Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering20111—
+2K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+2K070071Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc.20070—
+2K062248Azuryt Model CTL 1401, CO2 Surgical Laser SystemNorth American Clinical Lasers, Ltd.20060—
+2K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc.20062—
+2K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc.200514—
+2K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+2K014048Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp.200215—
+2K993942Litesaber 2000Laser Dental Innovations20001—
+3K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+3K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+3K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering20210—
+3K173827LightScalpelLightscalpel, LLC20180—
+3K123494SOLEAConvergent Dental, Inc.201331
+3K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+3K091115ECO2 Laser SystemLutronic Corporation200927—
+3K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+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—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc.20085—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S20070—
+3K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc.200781
+3K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+3K063141Omniguide Zero Flow ZF-T 150 Waveguide FiberOmniguide, Inc.20061—
+3K062423Omniguide Beampath Laser Beam Delivery SystemOmniguide, Inc.20061—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+3K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.200416—
+3K031795Reliant Laser SystemReliant Technologies, Inc.2003318—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+3K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003323—
+4K244060eCO2 3DLutronic Corporation20250—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K203241OmniGuide BeamPath OTO-U FiberOmniguide, Inc.20210—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+4K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+4K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123573Youlaser CO2 LaserQuanta System Spa201319—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K120932Opelaser Pro II and the Opelaser Lite IIThe Yoshida Dental Mfg. Co., Ltd.20120—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K102461FractoraInvasix, Ltd.201124—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+4K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc.20094—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K082809Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc.200812—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K073409Omniguide Sterile Waveguide Adapter SystemOmniguide, Inc.20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K052936Thermage Thermacool SystemThermage, Inc.2007103—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—
+4K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+5K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K221761SoleaConvergent Dental, Inc.202201
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—