510(k) Report

Devices descending from K853620

676 later devices reach Model XA-50 - CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997675—
+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—
+2K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003323—
+2K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+2K020408System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage WandsffArthrocare Corp.20020—
+2K980398Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd.19980—
+2K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998653—
+2K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970—
+3K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+3K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+3K123573Youlaser CO2 LaserQuanta System Spa201319—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K120932Opelaser Pro II and the Opelaser Lite IIThe Yoshida Dental Mfg. Co., Ltd.20120—
+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—
+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—
+3K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+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—
+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—
+3K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+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—
+3K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+3K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc.1999350—
+4K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+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—
+4K182669Youlaser CO2Quanta System Spa20181—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc.20180—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150027CYMAWhitecap Technologies, LLC20150—
+4K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+4K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K132754Neogen PSR SystemEnergist, Ltd.20132—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K102461FractoraInvasix, Ltd.201124—
+4K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD.201115—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+4K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+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—
+4K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—
+4K050412VapormaxTrimedyne, Inc.20052—
+4K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+4K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+4K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+4K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+5K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+5K244060eCO2 3DLutronic Corporation20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K231309SCAR 3El.En Electroinc Engineering Spa20230—
+5K221873NeoGen PSR SystemEnergist Limited20230—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—