FDA.reportPublic FDA data

Open surgical site internal light

Definition
An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.
GUDID devices
73
Last updated
2026-09-14 22:39:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08437016917350RutilightSWAN MEDICAL SL.RL-012026-09-04
08437016917404RutisideSWAN MEDICAL SL.RS-012026-09-04
00812432022747Bones and Nerves Disposable Single Leg Surgical IlluminatorLumitex, Inc.BNS-LT 10 01-S2023-08-11
00812432022754Bones and Nerves Surgical Solutions Disposable Bifurcated Surgical IlluminatorLumitex, Inc.BNS-LT 10 02-S2023-08-11
00812432022952Koros Surgical IlluminatorLumitex, Inc.7776-252023-08-11
00843210144184Altus Spine Bifurcated IlluminatorLumitex, Inc.0120312020-09-28
00812432020088Boss Instruments LightMat Surgical IlluminatorLumitex, Inc.0121182019-10-28
00812432022914DePuy TSS Retractor Light Strip 5-PackLumitex, Inc.0125122022-05-31
00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.0134172026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.0134202026-04-17
00888515319363BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.UA25502024-02-21
00888515319431BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.TA23342024-02-21
00888515319479BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.MM14622024-02-20
08881300212001KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITED555-01-012023-03-13
10885403285356Snowden-PencerSTERIS CORPORATION88-1004K2021-03-29
10885403285363Snowden-PencerSTERIS CORPORATION88-1005K2021-03-29
10885403285370Snowden-PencerSTERIS CORPORATION88-1006K2021-03-29
M678SLS0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCRover Lightsource series2018-06-27
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.0134452026-03-23
00812432023096Lumitex Surgical IlluminatorLumitex, Inc.0133102025-10-23
00812432023072L&K Biomed BluEX Surgical IlluminatorLumitex, Inc.BR06-0001S2025-12-11
00816744020118NICO MyriadNICO CORPORATIONNN-11102025-07-30
00816744021139NICO MyriadNICO CORPORATIONNN-11132025-07-30
00816744021313NICO MyriadNICO CORPORATIONNN-13102025-07-30
00816744021337NICO MyriadNICO CORPORATIONNN-13132025-07-30
008124320230654WEB Medical OA51S Surgical IlluminatorLumitex, Inc.4WEB-OA51S-LC2025-04-08
08437016917176RutilightSWAN MEDICAL SL.RL-012025-01-31
08437016917282RutisideSWAN MEDICAL SL.RS-012025-01-31
00816744020095NICO MyriadNICO CORPORATIONNN-10012024-11-13
00816744020101NICO MyriadNICO CORPORATIONNN-10002024-11-13
00812432023041Precision Spine TLIF Bifurcated Surgical IlluminatorLumitex, Inc.73-LC-53002024-10-25
00812432023058Lattus Spine Surgical IlluminatorLumitex, Inc.LAT00112024-06-21
00888515319455BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.OM21302024-02-21
00888515319462BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.OM12422024-02-21
10888515319360BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.UA25502024-02-21
10888515319438BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.TA23342024-02-21
10888515319476BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.MM14622024-02-20
00190376508085ATEC Light Cable SystemALPHATEC SPINE, INC.169-510-S2024-02-02
00190376508092ATEC Light Cable SystemALPHATEC SPINE, INC.169-520-S2024-02-02
00812432023010Thompson Surgical Instruments Lite Path Integrated Double 13mmLumitex, Inc.400402023-11-01
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCTracLux-SLS2023-05-29
00812432022396Spineart Wolf Cable AdaptorLumitex, Inc.MIS-IN 44 20-N2023-08-11
00812432022921Spineart Olympus Cable AdaptorLumitex, Inc.MIS-IN 44 30-N2023-08-11
00810025485344MiRus Bifurcated IlluminatorLumitex, Inc.17-5182023-08-11
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.0050112026-01-29
00812432021689Lumitex 4mm Universal Fiber Optic CableLumitex, Inc.0121392023-08-11
00812432021696Lumitex 3.5mm Fiber Optic CableLumitex, Inc.0120042023-08-11
00812432022655Orthofix Surgical IlluminatorLumitex, Inc.71-30402023-08-11
00812432022662Precision Spine TLIF Bifurcated Surgical IlluminatorLumitex, Inc.73-LC-52002023-08-11
00812432022716Life Instrument Life Light Surgical IlluminatorLumitex, Inc.703-0301-02023-08-11
00812432022730CoreLink Disposable Ring Clip 26mmLumitex, Inc.6460-0322023-08-11
00812432022761Bones and Nerves 3.75mm Reusable Fiber Optic CableLumitex, Inc.BNS-LT 10 03-N2023-08-11
00812432022778Alphatec Spine Wolf Cable AdaptorLumitex, Inc.735512023-08-11
00812432022785Alphatec Spine Olympus Cable AdaptorLumitex, Inc.735522023-08-11
00812432022792Alphatec Spine ACMI Cable AdaptorLumitex, Inc.735532023-08-11
00812432022808Alphatec Spine Storz Cable AdaptorLumitex, Inc.735542023-08-11
00812432022938Spineart ACMI Cable AdaptorLumitex, Inc.MIS-IN 44 40-N2023-08-11
00812432022969Invictus Development and Engineering Surgical IlluminatorLumitex, Inc.INTP-L-012023-08-11
00812432022976Camber Spine Technologies MIS Surgical IlluminatorLumitex, Inc.MDP-153-0012023-08-11
00812432022983Camber Spine Technologies Intermediary Fiber Optic CableLumitex, Inc.MDP-153-0022023-08-11
00812432022648Advanced Medical Solutions 3.5mm ACMI Bifurcated Reusable Light CableLumitex, Inc.AMS-0067-22023-07-28
08881300212018KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITED555-01-012023-03-13
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCROVER SLS2023-03-01
06974567745640Lightning X Products,IncWuxi Emsrun Technology Co., Ltd.LXLPL-FY2022-12-07
06974567743318EMSRUNWuxi Emsrun Technology Co., Ltd.PZBB0005-12022-12-06
06974567743325EMSRUNWuxi Emsrun Technology Co., Ltd.PZBB0005-22022-12-06
06974567743332EMSRUNWuxi Emsrun Technology Co., Ltd.PZBB0005-32022-12-06
06974567743349EMSRUNWuxi Emsrun Technology Co., Ltd.PZBB0005-42022-12-06
10812432022911DePuy TSS Retractor Light Strip 5-PackLUMITEX, INC.0125122022-05-31
00812432022815Spinal Elements PL Retractor LightLumitex, Inc.0126562022-04-25
00812432022723Stryker ATP Access System Lumitex, Inc.0126402022-04-01
00812432022907Zimmer Biomet Timberline Lateral Fusion System Wave GuideLumitex, Inc.8735-00422022-02-21
00812432021610K2M Canyon Retractor SystemsLumitex, Inc.0122192022-02-14