510(k) Report

Devices descending from K013043

703 later devices reach Candela Clearbeam Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153229SuperbiumBios S.R.L.20162—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152012EVO platformQuanta System Spa201537—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142093V20 SystemViora, Ltd.201432—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+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—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K102461FractoraInvasix, Ltd.201124—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+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
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+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—
+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—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+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—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+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—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—