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
+10K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+10K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K250200InbellaBody SystemInbella Medical, Inc.20250—
+10K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+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—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+10K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+10K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+10K240160EGPS Navigated InstrumentsAstura Medical20240—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+10K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+10K241656Eneka SelectifTermosalud20241—
+10K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+10K241600DermablateAsclepion Laser Technologies GmbH20240—
+10K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+10K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K233344Regenalase Laser SystemIpg Medical20240—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+10K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K232236EchoQuanta System Spa20230—
+10K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+10K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+10K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+10K231054V-LaserWontech Co., Ltd.20231—
+10K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+10K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+10K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+10K223558CUVIS-spineCurexo, Inc.20230—
+10K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K230293TheraFace MaskTherabody, Inc.202316—
+10K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+10K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223805AgnesAgnes Medical Co., Ltd.20233—
+10K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+10K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+10K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+10K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+10K223540AvalancheLase FamilyFotona D.O.O.20230—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+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—
+10K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K213674CellFX SystemPulse Biosciences, Inc.20220—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K213267Dynamis Pro FamilyFotona D.O.O.20222—
+10K222075CellFX SystemPulse Biosciences, Inc.20220—
+10K221671CellFX® SystemPulse Biosciences, Inc.20220—
+10K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+10K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+10K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+10K221407truSculpt iDCutera, Inc.20222—
+10K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+10K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+10K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+10K213350mJOULE System and AccessoriesSciton, Inc20220—
+10K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+10K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+10K212155TheraFace LEDTheragun, Inc.202142—
+10K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+10K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+10K212107ReversoIntelis Instruments, Ltd.20211—
+10K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+10K212238TheraFace MicrocurrentTheragun, Inc.20210—
+10K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+10K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—