510(k) Report

Devices descending from K912703

728 later devices reach Optica 60 ND;Yag Surgical Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231054V-LaserWontech Co., Ltd.20231—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K223680Eneka ProTermosalud20230—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K22079410PLTentech Co., Ltd.20220—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200616E>EyeCE-Swin20200—
+7K200104OxylightRaja Trading Company, Inc.202024—
+7K201111GentleMax Pro PlusCandela Corporation20203—
+7K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K200110SANDRO DualWontech Co., Ltd.20202—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+7K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K182173Joule SystemSciton, Inc20195—
+7K183452Vbeam Prima Laser SystemCandela Corp.20191—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K181510Echolaser X4El.En Electronic Engineering Spa20183—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180508Joule SystemSciton, Inc20183—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172413MT ONEM&T S.R.L.20175—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K161669Waterlase ExpressBiolase, Inc.201621—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K152714Quanta ForteQuanta System Spa201513—
+7K152012EVO platformQuanta System Spa201537—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151306SoleaConvergent Dental, Inc.20151—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K142093V20 SystemViora, Ltd.201432—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+7K131758Surgen UPollogen, Ltd.20135—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K130420SOLEAConvergent Dental, Inc.201321
+7K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+7K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+7K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K103455Spectra Laser SystemLutronic Corporation201192—
+7K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+7K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—