510(k) Report

Devices descending from K933322

727 later devices reach Zeiss Opmilas 144 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+9K162755PicocareWontech Co., Ltd.20179—
+9K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+9K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+9K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+9K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+9K163222Discovery Pico FamilyQuanta System Spa201630—
+9K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+9K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+9K152856Helios IIILaseroptek Co., Ltd.20165—
+9K160480PicoSure WorkstationCynosure, Inc.201620—
+9K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K150326PicoWay Laser SystemCandela Corporation201568—
+9K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+9K143105Picosure WorkstationCynosure, Inc.201549—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K142860Lumenis M22 SystemLumenis, Ltd.2015381
+9K142372Pico Way Laser SystemCandela Corpation201470—
+9K140837Lucid LYBio-Med USA, Inc.20140—
+9K140719Picosure WorkstationCynosure, Inc.201450—
+9K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+9K131839DC 7Dc International, LLC20130—
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+10K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+10K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+10K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+10K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+10K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K243488Vmat ProTermosalud20250—
+10K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K221865BTL-094BTL Industries, Inc.20230—
+10K210166Omnispec ED1000Medispec, Ltd.20230—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+10K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+10K212663Helios IV 785Laseroptek Co., Ltd.20223—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+10K212082PicoreBio-Med USA, Inc.20210—
+10K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+10K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+10K210226PicoSure WorkstationCynosure, LLC20213—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+10K202041Opera EvoQuanta System Spa20200—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K200786Venus EpileveVenus Concept USA, Inc.20200—
+10K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+10K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+10K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K191685PicoWay Laser SystemCandela Corporation201920—
+10K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+10K182997enlighten III Laser SystemCutera, Inc.20180—
+10K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+10K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+10K181272Picocare FamilyWontech Co., Ltd.20188—