510(k) Report

Devices descending from K000929

1,118 later devices reach Prolite Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+2K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+2K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+2K033946Lovely SystemMsq (M2), Ltd.2004737—
+2K031671Polaris WRSyneron Medical, Ltd.2003678—
+2K032460Profile BBL SystemSciton, Inc2003569—
+2K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K231054V-LaserWontech Co., Ltd.20231—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K223540AvalancheLase FamilyFotona D.O.O.20230—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K183156V-LaserWontech Co., Ltd.20193—
+3K181518Sebacia MicroparticlesSebacia, Inc.20180—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K113115Epicare YagLight Age, Inc.20120—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K090762LEDAQuantel Derma GmbH200946—
+3K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K063249BeamaxMedic Sharplight, Ltd.200758—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K053324Chromolite SystemChromogenex Plc200631—
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—