510(k) Report

Devices descending from K023954

1,117 later devices reach Altus Medical Coolglide Laser Systems and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K191086ExciplexClarteis20194—
+5K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+5K192430Epic 980Biolase, Inc.20195—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K183566CLARITY II Laser SystemLutronic Corporation201911
+5K182173Joule SystemSciton, Inc20195—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+5K182669Youlaser CO2Quanta System Spa20181—
+5K181868SHINY RPL SystemIds, Ltd.20181—
+5K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K162512truSculptCutera, Inc.20165—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K161503ORIONYerim Engineering Co., Ltd.20161—
+5K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+5K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+5K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+5K150664NeoLasSheaumann Laser, Inc.20151—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K150724SculpSureCynosure, Inc.201521—
+5K143559XP1000 RFBTL Industries, Inc.20157—
+5K150230SculpSureCynosure, Inc.201521—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K150051ExiliteBTL Industries, Inc.20150—
+5K150027CYMAWhitecap Technologies, LLC20150—
+5K143109XP300BTL Industries, Inc.20150—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K141986Elux 810 LaserEquipmed North America, Inc.20150—
+5K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+5K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+5K141555AdvantageLutronic Corporation201414—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140120EPIC 10Biolase, Inc.20141—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+5K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K130689Symphony RF GeneratorThermigen, Inc.201311—
+5K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—