510(k) Report

Devices descending from K033549

679 later devices reach Starlux Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K160821Tria SapphireTria Beauty, Inc.20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152790Venus Versa SystemVenus Concept, Ltd.20160—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K123573Youlaser CO2 LaserQuanta System Spa201319—
+4K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K101415TheraclearTheravant Corporation20101—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K091115ECO2 Laser SystemLutronic Corporation200927—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K090724OR-LightYperion Technology20090—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243488Vmat ProTermosalud20250—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K223727LavieenWontech Co., Ltd.20234—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K223680Eneka ProTermosalud20230—
+5K222685NIRA Model 2Dermal Photonics Corp20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—