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
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K192856MT OneM&T S.R.L.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170850Alma QAlma Lasers, Ltd.20172—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K153229SuperbiumBios S.R.L.20162—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K141237Harmony LiteAlma, Inc.20154—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K102461FractoraInvasix, Ltd.201124—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K091534Lightlas Model 532Lightmed Corp.200972—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K050218Wavelight SinonWavelight Laser Technologie AG20050—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K231948MediyagMedicreations, LLC20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—