510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+3K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+3K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+3K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+3K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+3K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+3K001589Candela Dynamic Cooling DeviceCandela Corp.20001,064—
+3K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+4K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+4K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+4K244060eCO2 3DLutronic Corporation20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+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—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+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—
+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—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+4K182669Youlaser CO2Quanta System Spa20181—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162851eLyx-PROIntelligent Sensory Concept SA20170—
+4K160312Fraxis DuoIlooda 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—
+4K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+4K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+4K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K150027CYMAWhitecap Technologies, LLC20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K141658Light ScalpelLightscalpel, LLC20142—
+4K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+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—
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K134017GigalaserPowermedic Aps20141—
+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—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K131758Surgen UPollogen, Ltd.20135—
+4K132754Neogen PSR SystemEnergist, Ltd.20132—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K120460SmartluxMedmix Co., Ltd.201218—
+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—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—