510(k) Report

Devices descending from K001527

365 later devices reach Fotona Fidelis ER: Yag Laser System and Accesories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+1K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+1K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+1K012127Pulsemaster Erbium Dental Laser SystemAmerican Dental Technologies, Inc.2001241—
+2K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+2K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+2K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+2K161669Waterlase ExpressBiolase, Inc.201621—
+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—
+2K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+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—
+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—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K213428EdgeProBiolase, Inc.20210—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+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—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K150664NeoLasSheaumann Laser, Inc.20151—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K152012EVO platformQuanta System Spa201537—
+3K151306SoleaConvergent Dental, Inc.20151—
+3K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+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
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+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—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+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—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K244060eCO2 3DLutronic Corporation20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K171648BM.IrisBluecore Co., Ltd.20172—