510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+11K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241656Eneka SelectifTermosalud20241—
+11K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+11K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+11K233473Deka LotusEl.En S.P.A.20241—
+11K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+11K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+11K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+11K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+11K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K232106Air Gap FiberWontech Co., Ltd.20240—
+11K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+11K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+11K232236EchoQuanta System Spa20230—
+11K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+11K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+11K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+11K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+11K222790F65 Laser SystemLumenis Be, Ltd.20233—
+11K230293TheraFace MaskTherabody, Inc.202316—
+11K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+11K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+11K223805AgnesAgnes Medical Co., Ltd.20233—
+11K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+11K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+11K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+11K222221Deka HelixEl.En Electronic Engineering Spa20231—
+11K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+11K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+11K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+11K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+11K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+11K213674CellFX SystemPulse Biosciences, Inc.20220—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K222075CellFX SystemPulse Biosciences, Inc.20220—
+11K221671CellFX® SystemPulse Biosciences, Inc.20220—
+11K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+11K221407truSculpt iDCutera, Inc.20222—
+11K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+11K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+11K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+11K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+11K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+11K212155TheraFace LEDTheragun, Inc.202142—
+11K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+11K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+11K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+11K212107ReversoIntelis Instruments, Ltd.20211—
+11K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+11K212238TheraFace MicrocurrentTheragun, Inc.20210—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+11K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+11K202199BTL-899STBtl20216—
+11K193266MIINMedico USA, Inc.20210—
+11K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+11K200693K2 MobileHulaser, Inc.20202—
+11K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+11K202041Opera EvoQuanta System Spa20200—
+11K201406PicowonWontech Co., Ltd.20200—
+11K200736Stardust MedI.T.S. Group S.R.L.20200—
+11K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+11K200241TempSure SystemCynosure, LLC202013—
+11K193486Epic 980Biolase, Inc.20202—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K191855EmFace DeviceInmode MD, Ltd.20191—
+11K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+11K190443MMSphereGalactic Beauty, LLC201942—
+11K181095RF-ReliefEl Global Trade, Ltd.20181—
+11K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+11K180044SIROLaser BlueDentsply Sirona201812—
+11K173199PicoSure WorkstationCynosure, Inc.20189—
+11K172302InMode PLUS SystemInmode MD, Ltd.201713—
+11K172771Epic Pro 940Biolase, Inc.20171—
+11K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+11K170984LG Beauty Led MaskLg Electronics201793—
+11K162755PicocareWontech Co., Ltd.20179—
+11K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+11K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+11K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+11K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+11K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+11K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+11K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+11K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+11K160691Acne Light Therapy WandZuko, Inc.201650—
+11K152856Helios IIILaseroptek Co., Ltd.20165—
+11K160480PicoSure WorkstationCynosure, Inc.201620—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K153527PicoWay Laser SystemSyneron Candela Corporation201641—