510(k) Report

Devices descending from K072034

263 later devices reach Diode Medical Laser Family, Models 4, 6, 30 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110375Blueshine's Gold SeriesBlueshine Srl20124—
+1K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+1K100558Quanta Diode Laser SystemQuanta System Spa201068—
+1K090762LEDAQuantel Derma GmbH200946—
+1K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+1K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+1K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+2K261964Echolaser X4Elesta S.P.A20260—
+2K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+2K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+2K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+2K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+2K222701MANTA LaserSqualus Med, Ltd.20222—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+2K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+2K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+2K151629Guardian 1000Quanta System Spa20150—
+2K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+2K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+2K140120EPIC 10Biolase, Inc.20141—
+2K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+2K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+2K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+2K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+2K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+2K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+2K121327Diolase 10SBiolase Technology, Inc.20132—
+2K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+2K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+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—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K094049Stlase Diode LaserDental Photonics, Inc.201023—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+3K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+3K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+3K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+3K233344Regenalase Laser SystemIpg Medical20240—
+3K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K193656SkyPulseFotona D.O.O.202011—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+3K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+3K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+3K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+3K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+3K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+3K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+3K173285Joule SystemSciton, Inc20185—
+3K171702Exciplex308nmClarteis20175—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+3K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131839DC 7Dc International, LLC20130—
+3K130465EPIC 10SBiolase Technology, Inc.20130—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+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—
+3K111689StlaseDental Photonics, Inc.201222—
+3K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K251730LIA Console (542-7)Leadoptik, Inc.20250—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+4K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+4K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+4K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—