510(k) Report

Devices descending from K053540

299 later devices reach Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+1K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+1K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+1K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+1K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+1K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+1K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+1K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+2K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+2K110375Blueshine's Gold SeriesBlueshine Srl20124—
+2K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+2K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+2K100558Quanta Diode Laser SystemQuanta System Spa201068—
+2K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+2K090762LEDAQuantel Derma GmbH200946—
+2K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+2K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+2K082938EzlaseBiolase Technology, Inc.200850—
+2K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+2K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+2K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+3K261964Echolaser X4Elesta S.P.A20260—
+3K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+3K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K222701MANTA LaserSqualus Med, Ltd.20222—
+3K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K193656SkyPulseFotona D.O.O.202011—
+3K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+3K173285Joule SystemSciton, Inc20185—
+3K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+3K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+3K151629Guardian 1000Quanta System Spa20150—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K140120EPIC 10Biolase, Inc.20141—
+3K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+3K132976AdvatxAdvalight Aps20141—
+3K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+3K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K121327Diolase 10SBiolase Technology, Inc.20132—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+3K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+3K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+3K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+3K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K094049Stlase Diode LaserDental Photonics, Inc.201023—
+3K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193367elysion-proHigh Technology Products S.L.U20203—