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
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—
+5K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+5K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121435Silkn BlueHome Skinovations, Ltd.2013125—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+5K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110301Silk'n FXHome Skinovations, Ltd.201166—
+5K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K110685Flexiva TractipBoston Scientific Corp20112—
+5K110686AccutracBoston Scientific Corp20110—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K103415Tanda MaxPharos Life Corporation20110—
+5K100628PlasmaluxlsDaavlin Distributing Co.20100—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+5K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K091467Baby QuasarSilver Bay, LLC20100—
+5K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+5K093168Mediflash and EsteflashDermeo20100—
+5K090744CLAROClrs Technology Corporation20101—
+5K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+5K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+5K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+5K090724OR-LightYperion Technology20090—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083730IsolazAesthera Corporation20093—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+5K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+5K063249BeamaxMedic Sharplight, Ltd.200758—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+5K053324Chromolite SystemChromogenex Plc200631—
+5K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+5K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+5K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+5K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+5K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+5K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+5K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—