510(k) Report

Devices descending from K041710

353 later devices reach Versawave Dental ER:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+1K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+1K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+1K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+1K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+1K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+2K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+2K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+2K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+2K150664NeoLasSheaumann Laser, Inc.20151—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+2K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+2K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+2K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+2K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K073411LiteduoLight Instruments20081—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+3K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+3K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+3K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+3K171227StarWalkerFotona D.O.O.20177—
+3K161669Waterlase ExpressBiolase, Inc.201621—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K152012EVO platformQuanta System Spa201537—
+3K151306SoleaConvergent Dental, Inc.20151—
+3K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K130420SOLEAConvergent Dental, Inc.201321
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K221761SoleaConvergent Dental, Inc.202201
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K213428EdgeProBiolase, Inc.20210—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K173285Joule SystemSciton, Inc20185—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K152737Lite TouchFocus Medical, LLC20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132976AdvatxAdvalight Aps20141—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—