510(k) Report

Devices descending from K033549

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K141868Tria FanpTria Beauty, Inc.20140—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090744CLAROClrs Technology Corporation20101—
+3K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+3K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+3K090399Trios SystemViora, Ltd.20090—
+3K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K083730IsolazAesthera Corporation20093—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+3K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+3K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+3K080932Mosaic Laser SystemLutronic Corporation20086—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+3K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+4K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200786Venus EpileveVenus Concept USA, Inc.20200—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K192331LaseMD LEO Laser SystemLutronic Global20190—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182173Joule SystemSciton, Inc20195—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K180406Ellipse YdunEllipse A/S20180—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K171009LASEMD Laser SystemLutronic Corporation20178—