510(k) Report

Devices descending from K971711

978 later devices reach Somnus Model 215 Electrosurgical Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K23299210THERMATentech, Inc.20230—
+9K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+9K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+9K232236EchoQuanta System Spa20230—
+9K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+9K231146AliTightAlic Iotech, LLC20230—
+9K230663DensityJeisys Medical, Inc.20232—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K230293TheraFace MaskTherabody, Inc.202316—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+9K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+9K221865BTL-094BTL Industries, Inc.20230—
+9K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K210166Omnispec ED1000Medispec, Ltd.20230—
+9K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+9K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+9K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+9K221989The OligioWontech Co., Ltd.20222—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K193266MIINMedico USA, Inc.20210—
+9K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K201406PicowonWontech Co., Ltd.20200—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+9K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K193486Epic 980Biolase, Inc.20202—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+9K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+9K190443MMSphereGalactic Beauty, LLC201942—
+9K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+9K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K173199PicoSure WorkstationCynosure, Inc.20189—
+9K172771Epic Pro 940Biolase, Inc.20171—
+9K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+9K170984LG Beauty Led MaskLg Electronics201793—
+9K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+9K172096FraxisIlooda Co,., Ltd.20172—
+9K170325Secret RFIlooda Co,., Ltd.201710—
+9K162755PicocareWontech Co., Ltd.20179—
+9K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K163415SlimShape SystemSyneron Medical, Ltd.201714—
+9K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+9K162512truSculptCutera, Inc.20165—
+9K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+9K160691Acne Light Therapy WandZuko, Inc.201650—
+9K152856Helios IIILaseroptek Co., Ltd.20165—
+9K160480PicoSure WorkstationCynosure, Inc.201620—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+9K153717Venus Versa SystemVenus Concept, Ltd.20161—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K152611V20 systemViora, Ltd.20164—
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K143559XP1000 RFBTL Industries, Inc.20157—
+9K150035V10 systemViora, Ltd.201531—
+9K150326PicoWay Laser SystemCandela Corporation201568—
+9K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+9K143109XP300BTL Industries, Inc.20150—
+9K143105Picosure WorkstationCynosure, Inc.201549—
+9K142372Pico Way Laser SystemCandela Corpation201470—
+9K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+9K140719Picosure WorkstationCynosure, Inc.201450—
+9K130689Symphony RF GeneratorThermigen, Inc.201311—
+9K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+9K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+10K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+10K253504Volnewmer™Classys, Inc.20260—