510(k) Report

Devices descending from K022266

705 later devices reach Aurora SR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+6K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+6K232236EchoQuanta System Spa20230—
+6K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230293TheraFace MaskTherabody, Inc.202316—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+6K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+6K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+6K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+6K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+6K212155TheraFace LEDTheragun, Inc.202142—
+6K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+6K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+6K212238TheraFace MicrocurrentTheragun, Inc.20210—
+6K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192430Epic 980Biolase, Inc.20195—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K190443MMSphereGalactic Beauty, LLC201942—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K170984LG Beauty Led MaskLg Electronics201793—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K160691Acne Light Therapy WandZuko, Inc.201650—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K131839DC 7Dc International, LLC20130—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K111689StlaseDental Photonics, Inc.201222—
+7K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+7K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—