510(k) Report

Devices descending from K012398

714 later devices reach Diomed 15 Diode Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K094049Stlase Diode LaserDental Photonics, Inc.201023—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K22079410PLTentech Co., Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202172StarWalkerFotona D.O.O.20203—
+5K192621Medical RFTriworks Group Srl20200—
+5K200616E>EyeCE-Swin20200—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K183156V-LaserWontech Co., Ltd.20193—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180508Joule SystemSciton, Inc20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K173285Joule SystemSciton, Inc20185—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171702Exciplex308nmClarteis20175—
+5K172413MT ONEM&T S.R.L.20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K152737Lite TouchFocus Medical, LLC20160—