510(k) Report

Devices descending from K912029

676 later devices reach Ultrapulse (TM) Carbon Dioxide Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+4K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+4K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—
+4K053457Vapormax IITrimedyne, Inc.20051—
+4K014290Entec Plasma WandsArthrocare Corp.2002119—
+4K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+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—
+5K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K231309SCAR 3El.En Electroinc Engineering Spa20230—
+5K221873NeoGen PSR SystemEnergist Limited20230—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+5K211534RevoLix HTLLisa Laser Products GmbH20220—
+5K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193656SkyPulseFotona D.O.O.202011—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+5K180423Empower H65Quanta System Spa20181—
+5K173285Joule SystemSciton, Inc20185—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K163449HyPHo Laser SystemHyper Photonics Srl20170—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+5K163197Cook Holmium Laser FiberCook Incorporated20170—
+5K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+5K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+5K170331Cyber HoQuanta System Spa20179—
+5K163009LithoQuanta System Spa201612—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+5K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+5K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+5K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+5K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+5K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K110685Flexiva TractipBoston Scientific Corp20112—
+5K110686AccutracBoston Scientific Corp20110—
+5K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+5K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+5K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+5K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+5K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—