510(k) Report

Devices descending from K013365

1,127 later devices reach Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K22079410PLTentech Co., Ltd.20220—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K202172StarWalkerFotona D.O.O.20203—
+4K192621Medical RFTriworks Group Srl20200—
+4K200616E>EyeCE-Swin20200—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+4K172413MT ONEM&T S.R.L.20175—
+4K171227StarWalkerFotona D.O.O.20177—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152012EVO platformQuanta System Spa201537—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+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—
+4K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+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—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+4K111026ApolloPollogen, Ltd.201114—
+4K111784Venus Swan SystemVenus Concept, Ltd.20111—
+4K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K102461FractoraInvasix, Ltd.201124—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—