510(k) Report

Devices descending from K020339

695 later devices reach Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K231948MediyagMedicreations, LLC20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+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—
+4K22079410PLTentech Co., Ltd.20220—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+4K213594Echolaser X4Elesta S.P.A20221—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K192621Medical RFTriworks Group Srl20200—
+4K200616E>EyeCE-Swin20200—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K180508Joule SystemSciton, Inc20183—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K173285Joule SystemSciton, Inc20185—
+4K171702Exciplex308nmClarteis20175—
+4K172413MT ONEM&T S.R.L.20175—
+4K171227StarWalkerFotona D.O.O.20177—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+4K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K133405MinnieElettronica Valseriana Srl20140—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131839DC 7Dc International, LLC20130—
+4K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K130465EPIC 10SBiolase Technology, Inc.20130—
+4K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+4K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+4K111689StlaseDental Photonics, Inc.201222—
+4K111026ApolloPollogen, Ltd.201114—
+4K111784Venus Swan SystemVenus Concept, Ltd.20111—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—