510(k) Report

Devices descending from K980537

1,242 later devices reach ND: Yag Accessory for Photoderm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K141555AdvantageLutronic Corporation201414—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K133405MinnieElettronica Valseriana Srl20140—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122493GenesisplusCutera, Inc.201318—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121435Silkn BlueHome Skinovations, Ltd.2013125—
+4K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+4K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K113115Epicare YagLight Age, Inc.20120—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K111026ApolloPollogen, Ltd.201114—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K111784Venus Swan SystemVenus Concept, Ltd.20111—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K110301Silk'n FXHome Skinovations, Ltd.201166—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K103415Tanda MaxPharos Life Corporation20110—
+4K100628PlasmaluxlsDaavlin Distributing Co.20100—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K091467Baby QuasarSilver Bay, LLC20100—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+4K093168Mediflash and EsteflashDermeo20100—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090744CLAROClrs Technology Corporation20101—
+4K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+4K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+4K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+4K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+4K090724OR-LightYperion Technology20090—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+4K083730IsolazAesthera Corporation20093—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—