510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K180338CellulizeWard Photonics, LLC20182—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K181659Avologi ENEOPremier North America, Inc.20184—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+6K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K180320dpl IIa PanelLed Technologies, Inc.201814—
+6K180426Empower H35Quanta System Spa20181—
+6K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+6K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+6K172111Vevazz LEDVevazz, LLC20170—
+6K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+6K171702Exciplex308nmClarteis20175—
+6K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+6K172025Litho 60Quanta System Spa20178—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+6K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+6K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+6K162784Silk'n HSTHome Skinovations, Ltd.20171—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K160368EVO platformQuanta System Spa201636—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+6K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131805Inpulse LaserIncisive, Inc.20130—
+6K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K130413Pinpointe FootlaserNuvolase, Inc.20130—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K103338CooltouchNew Star Lasers, Inc.201101
+6K110370Q-ClearLight Age, Inc.201135—
+6K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+6K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K101415TheraclearTheravant Corporation20101—
+6K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+6K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+6K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+6K081570DPL Therapy SystemLed Technologies, LLC200811
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871