510(k) Report

Devices descending from K002421

744 later devices reach Candela Mid IR Diode Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171648BM.IrisBluecore Co., Ltd.20172—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K163222Discovery Pico FamilyQuanta System Spa201630—
+8K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140837Lucid LYBio-Med USA, Inc.20140—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+8K131839DC 7Dc International, LLC20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243488Vmat ProTermosalud20250—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K241406LavieenWontech Co., Ltd.20242—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K221865BTL-094BTL Industries, Inc.20230—
+9K210166Omnispec ED1000Medispec, Ltd.20230—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+9K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212082PicoreBio-Med USA, Inc.20210—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—