510(k) Report

Devices descending from K933880

1,212 later devices reach SL Series Surgical Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K193266MIINMedico USA, Inc.20210—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+6K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K180338CellulizeWard Photonics, LLC20182—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+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—
+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—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172111Vevazz LEDVevazz, LLC20170—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+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—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+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—
+6K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+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—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K141065Constellation Vision SystemAlcon Research, Ltd.201426
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133774AtovenBio-Med USA, Inc.20146—