510(k) Report

Devices descending from K952681

1,700 later devices reach Stryker Hummer II Microdebrider System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+11K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+11K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+11K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+11K253342PICO-KSpeclipse, Inc.20251—
+11K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+11K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K251730LIA Console (542-7)Leadoptik, Inc.20250—
+11K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+11K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+11K253344Bellus-QSpeclipse, Inc.20250—
+11K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+11K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+11K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+11K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+11K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+11K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K251094Alma VeilWontech Co., Ltd.20250—
+11K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+11K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+11K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+11K243587PureLift GLOWXtreem Pulse, LLC20251—
+11K250281Deka LotusEl.En S.P.A.20250—
+11K243330LYMA Laser PROLyma Life, Ltd.20250—
+11K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+11K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+11K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+11K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+11K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+11K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+11K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+11K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+11K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+11K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+11K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+11K232106Air Gap FiberWontech Co., Ltd.20240—
+11K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+11K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+11K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+11K230167BACK 4Swims America Corp20230—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+11K230037BACK 3Swims America Corp20230—
+11K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+11K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+11K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+11K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+11K223110truSculpt iDCutera, Inc.20221—
+11K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+11K222698CUVIS-spineCurexo, Inc.20220—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+11K221427V-LaserWontech Co., Ltd.20222—
+11K212663Helios IV 785Laseroptek Co., Ltd.20223—
+11K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+11K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K220025ARx® Spinal SystemLife Spine, Inc.20220—
+11K212891TempSure SystemCynosure, LLC20221—
+11K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+11K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+11K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+11K211107BTL-899 FPBTL Industries, Inc.20213—
+11K210948Omnilux CLEARGlobalmed Technologies202139—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K210226PicoSure WorkstationCynosure, LLC20213—
+11K200693K2 MobileHulaser, Inc.20202—
+11K202041Opera EvoQuanta System Spa20200—
+11K200070ARx Spinal SystemLife Spine, Inc.20209—
+11K193486Epic 980Biolase, Inc.20202—
+11K193426Elite iQCynosure, LLC20201—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+11K191685PicoWay Laser SystemCandela Corporation201920—
+11K191629faceLITEIsmart Marketing Svcs, Ltd.201971—