510(k) Report

Devices descending from K974789

653 later devices reach Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+1K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+1K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc.1999350—
+2K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+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—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+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—
+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—
+2K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+2K050412VapormaxTrimedyne, Inc.20052—
+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—
+2K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+2K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+2K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+2K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+3K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+3K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+3K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+3K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+3K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+3K132975Sphinx JRAllmed Systems, Inc.20141—
+3K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+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—
+3K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+3K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+3K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+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—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+3K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+3K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+3K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+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—
+3K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K082809Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc.200812—
+3K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+3K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+3K080932Mosaic Laser SystemLutronic Corporation20086—
+3K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+3K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+3K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+3K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—
+3K053457Vapormax IITrimedyne, Inc.20051—
+3K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+3K014290Entec Plasma WandsArthrocare Corp.2002119—
+3K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+4K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+4K244060eCO2 3DLutronic Corporation20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+4K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+4K211534RevoLix HTLLisa Laser Products GmbH20220—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K211362SCAR 3El.En Electronic Engineering Spa20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—