510(k) Report

Devices descending from K013825

740 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223680Eneka ProTermosalud20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K22079410PLTentech Co., Ltd.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202172StarWalkerFotona D.O.O.20203—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200616E>EyeCE-Swin20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K180508Joule SystemSciton, Inc20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172413MT ONEM&T S.R.L.20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152012EVO platformQuanta System Spa201537—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K131758Surgen UPollogen, Ltd.20135—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—