510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+10K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+10K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+10K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+10K252187Aura Glide (FC40)Aura Medical, LLC20250—
+10K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K250852CoolfaseAsterasys Co., Ltd.20250—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K242859VEGAIbramed Equipamentos Médicos20250—
+10K251843Erchonia EVRLErchonia Corporation20250—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251327XERFLutronic Corporation202501
+10K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+10K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+10K251632Optimas MAX SystemInMode, Ltd.20251—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+10K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+10K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+10K242241SunnyShenB Co., Ltd.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K243488Vmat ProTermosalud20250—
+10K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+10K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+10K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+10K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+10K240311JETT Medical IICompex, Spol, S.R.O.20250—
+10K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+10K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+10K241656Eneka SelectifTermosalud20241—
+10K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+10K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+10K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K240248Volnewmer™Classys, Inc.20241—
+10K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K23299210THERMATentech, Inc.20230—
+10K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K232236EchoQuanta System Spa20230—
+10K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+10K231146AliTightAlic Iotech, LLC20230—
+10K230663DensityJeisys Medical, Inc.20232—
+10K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+10K230293TheraFace MaskTherabody, Inc.202316—
+10K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+10K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+10K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+10K221865BTL-094BTL Industries, Inc.20230—
+10K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+10K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+10K210166Omnispec ED1000Medispec, Ltd.20230—
+10K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+10K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+10K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+10K221989The OligioWontech Co., Ltd.20222—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+10K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+10K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+10K212155TheraFace LEDTheragun, Inc.202142—
+10K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+10K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+10K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+10K212238TheraFace MicrocurrentTheragun, Inc.20210—
+10K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+10K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K193266MIINMedico USA, Inc.20210—
+10K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+10K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+10K200693K2 MobileHulaser, Inc.20202—
+10K202041Opera EvoQuanta System Spa20200—
+10K201406PicowonWontech Co., Ltd.20200—
+10K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—
+10K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+10K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+10K191065Venus VivaTMVenus Concept USA, Inc.20200—
+10K193486Epic 980Biolase, Inc.20202—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K192545PotenzaJeisys Medical Incorporated202020—
+10K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—