510(k) Report

Devices descending from K946304

1,420 later devices reach Coherent Family of CO2 Surgical Laser Scanner Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180508Joule SystemSciton, Inc20183—
+5K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+5K180423Empower H65Quanta System Spa20181—
+5K173285Joule SystemSciton, Inc20185—
+5K172413MT ONEM&T S.R.L.20175—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K163449HyPHo Laser SystemHyper Photonics Srl20170—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+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—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+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—
+5K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151337StrialiteCentre Light Solutions, LLC20160—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—
+5K152714Quanta ForteQuanta System Spa201513—
+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—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+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—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131758Surgen UPollogen, Ltd.20135—
+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—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+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—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+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—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—