510(k) Report

Devices descending from K014234

784 later devices reach Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+4K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240752Deka ToroEl.En S.P.A.20240—
+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—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K22079410PLTentech Co., Ltd.20220—
+4K220853PicoWay Laser SystemCandela Corporation20221—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K212127PicocaremajestyWontech Co., Ltd.20226—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K201773PicohiHironic Co., Ltd.20215—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200616E>EyeCE-Swin20200—
+4K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K173700PICOPLUS Laser SystemLutronic Corporation20187—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K152714Quanta ForteQuanta System Spa201513—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+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—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—