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
+4K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+4K182669Youlaser CO2Quanta System Spa20181—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc.20180—
+4K180423Empower H65Quanta System Spa20181—
+4K173285Joule SystemSciton, Inc20185—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K163449HyPHo Laser SystemHyper Photonics Srl20170—
+4K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+4K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+4K170331Cyber HoQuanta System Spa20179—
+4K163009LithoQuanta System Spa201612—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+4K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K150027CYMAWhitecap Technologies, LLC20150—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K141658Light ScalpelLightscalpel, LLC20142—
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+4K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+4K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+4K110685Flexiva TractipBoston Scientific Corp20112—
+4K110686AccutracBoston Scientific Corp20110—
+4K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+4K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+4K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+4K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+4K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+4K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+4K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+4K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—
+5K260100MOSES Raydar™Boston Scientific Corporation20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+5K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232106Air Gap FiberWontech Co., Ltd.20240—
+5K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+5K230077LaserMENeauvia North America20232—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K231309SCAR 3El.En Electroinc Engineering Spa20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222685NIRA Model 2Dermal Photonics Corp20230—