510(k) Report

Devices descending from K941841

1,178 later devices reach Smartscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K134017GigalaserPowermedic Aps20141—
+4K132976AdvatxAdvalight Aps20141—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122493GenesisplusCutera, Inc.201318—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K120460SmartluxMedmix Co., Ltd.201218—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113115Epicare YagLight Age, Inc.20120—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K090399Trios SystemViora, Ltd.20090—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+4K073000LumaprobeClareblend, Inc.20080—
+4K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+4K080638CLAROClrs Technology Corporation20082—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+4K063074Candela 3630 Laser SystemCandela Corp.2006179—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+4K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+4K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+4K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+4K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+4K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+4K043032Dealight IplEuropro, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K014253Dermachiller 4Paradigm Trex, LLC200250—
+4K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K250189AdvaTxAdvalight Aps20250—