510(k) Report

Devices descending from K954934

701 later devices reach Candela SPTL Long Pulse/Tunable Pulsed Dye Lase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202172StarWalkerFotona D.O.O.20203—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K180406Ellipse YdunEllipse A/S20180—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+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—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K153229SuperbiumBios S.R.L.20162—
+6K160368EVO platformQuanta System Spa201636—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152012EVO platformQuanta System Spa201537—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142093V20 SystemViora, Ltd.201432—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K102461FractoraInvasix, Ltd.201124—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K093465Fusion SystemEclipsemed Global, Inc.20100—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+6K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080374Biosyag Medical SystemBios S.R.L.20082—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—