510(k) Report

Devices descending from K002421

744 later devices reach Candela Mid IR Diode Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K223680Eneka ProTermosalud20230—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K221873NeoGen PSR SystemEnergist Limited20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K22079410PLTentech Co., Ltd.20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202172StarWalkerFotona D.O.O.20203—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200616E>EyeCE-Swin20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K180508Joule SystemSciton, Inc20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172413MT ONEM&T S.R.L.20175—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152012EVO platformQuanta System Spa201537—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K131758Surgen UPollogen, Ltd.20135—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—