510(k) Report

Devices descending from K931762

701 later devices reach Candela SPTL Pulsed Dye Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K200104OxylightRaja Trading Company, Inc.202024—
+7K201111GentleMax Pro PlusCandela Corporation20203—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K200110SANDRO DualWontech Co., Ltd.20202—
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183452Vbeam Prima Laser SystemCandela Corp.20191—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K181510Echolaser X4El.En Electronic Engineering Spa20183—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K180406Ellipse YdunEllipse A/S20180—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+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—
+7K161669Waterlase ExpressBiolase, Inc.201621—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K153229SuperbiumBios S.R.L.20162—
+7K160368EVO platformQuanta System Spa201636—
+7K152714Quanta ForteQuanta System Spa201513—
+7K152012EVO platformQuanta System Spa201537—
+7K151306SoleaConvergent Dental, Inc.20151—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K142093V20 SystemViora, Ltd.201432—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+7K130420SOLEAConvergent Dental, Inc.201321
+7K122200A3F FrationalPollogen, Ltd.20130—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+7K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+7K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+7K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K102461FractoraInvasix, Ltd.201124—
+7K103455Spectra Laser SystemLutronic Corporation201192—
+7K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+7K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+7K101321Ematrix CO2Syneron Medical, Ltd.20102—
+7K092734E-Light LineEspansione Marketing S.P.A20102—
+7K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+7K093465Fusion SystemEclipsemed Global, Inc.20100—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+7K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+7K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+7K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K080374Biosyag Medical SystemBios S.R.L.20082—
+7K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+7K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K253765Vanish ProDdc Technologies, Inc.20260—
+8K260632Laser Thermal Therapy KitElesta S.P.A20260—
+8K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K252877SANDRO DualWontech Co., Ltd.20250—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—