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
+9K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250165PastelleWontech Co., Ltd.20250—
+9K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+9K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+9K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+9K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K250125LMNT O2Xplr, Ltd.20250—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243929Oligio XWontech Co., Ltd.20250—
+9K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+9K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241535Vybe RF IIShenB Co., Ltd.20240—
+9K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+9K241102Luna 4 plusForeo, Inc.20245—
+9K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+9K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+9K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+9K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+9K231146AliTightAlic Iotech, LLC20230—
+9K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+9K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K230077LaserMENeauvia North America20232—
+9K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+9K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+9K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+9K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+9K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+9K223147myLEDmaskMyblend20234—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223680Eneka ProTermosalud20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K222701MANTA LaserSqualus Med, Ltd.20222—
+9K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K222369PURE LaserEndymed Medical, Ltd.20220—
+9K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+9K212561MTX-C1Ilooda Co,., Ltd.20220—
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+9K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—