510(k) Report

Devices descending from K963339

675 later devices reach Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+4K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+4K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+4K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+4K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K141658Light ScalpelLightscalpel, LLC20142—
+4K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+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—
+4K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+4K132975Sphinx JRAllmed Systems, Inc.20141—
+4K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+4K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+4K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+4K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+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—
+4K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+4K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+4K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+4K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+4K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+4K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+4K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+4K053457Vapormax IITrimedyne, Inc.20051—
+4K014290Entec Plasma WandsArthrocare Corp.2002119—
+4K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+5K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.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—
+5K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+5K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+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—
+5K230077LaserMENeauvia North America20232—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+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—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—