510(k) Report

Devices descending from K010005

855 later devices reach Cynosure Photogenica DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K193201BTL-785FBtl20208—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+6K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+6K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172181micro IPLEl Global Trade, Ltd.20170—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170269Hee HR MiniOriental Inspiration Limited201713—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161089sensiLight MiniEl Global Trade, Ltd.20164—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K141242Glide DeviceHome Skinovations, Ltd.201419—
+6K140120EPIC 10Biolase, Inc.20141—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K120510TranscendSyneron Medical, Ltd.201318—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122966XP200Btl Industries, Ltd.20131—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K081408Ellipse MultiflexEllipse A/S20087—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—