FDA.report

Operating room light system

Definition
An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.
GUDID devices
277
Last updated
2026-04-01 16:43:10

Related Product Codes

CodeDeviceSpecialtyClassDevices
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2153
FTDLamp, SurgicalGeneral, Plastic Surgery2107
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery24
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery24
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery13
KXJTable, RadiologicRadiology23
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery12
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery12
FQPLamp, Operating-RoomGeneral, Plastic Surgery21
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery21
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery21
IWYHolder, Head, RadiographicRadiology11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
B510SL700700LED1ADVANCED SURGICAL LAMP ADVANCED INSTRUMENTATIONS, INC.SL700/700 LED2026-03-24
00850053798016APEX LEDBurton Medical, LLCAPLED2026-02-19
08800053093767S300 SeriesDENTIS CO. ,LTDS300-200002025-02-19
08800053093774S300 SeriesDENTIS CO. ,LTDS300-210002025-02-19
08800053093781S300 Series DENTIS CO. ,LTDS300-210012025-02-19
08800053093798S300 SeriesDENTIS CO. ,LTDS300-220002025-02-19
08800053093804S300 SeriesDENTIS CO. ,LTDS300-220012025-02-19
08800053093828S300 SeriesDENTIS CO. ,LTDS300-230002025-02-19
08800053093835S300 SeriesDENTIS CO. ,LTDS300-230012025-02-19
08800053093842S300 SeriesDENTIS CO. ,LTDS300-240002025-02-19
08800053093859S300 SeriesDENTIS CO. ,LTDS300-240012025-02-19
08800053093866S300 SeriesDENTIS CO. ,LTDS300-250002025-02-19
08800053093873S300 SeriesDENTIS CO. ,LTDS300-250012025-02-19
08800053093880S300 SeriesDENTIS CO. ,LTDS300-300002025-02-19
08800053093897S300 SeriesDENTIS CO. ,LTDS300-310002025-02-19
08800053093903S300 SeriesDENTIS CO. ,LTDS300-310012025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDS300-320002025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDS300-320012025-02-19
08800053093941S300 SeriesDENTIS CO. ,LTDS300-360002025-02-19
08800053093958S300 SeriesDENTIS CO. ,LTDS300-360012025-02-19
08800053093972S300 SeriesDENTIS CO. ,LTDS300-370002025-02-19
08800053093989S300 SeriesDENTIS CO. ,LTDS300-370012025-02-19
08800053094009S300 SeriesDENTIS CO. ,LTDS300-201002025-02-19
08800053094016S300 SeriesDENTIS CO. ,LTDS300-211002025-02-19
08800053094023S300 SeriesDENTIS CO. ,LTDS300-211012025-02-19
08800053094030S300 SeriesDENTIS CO. ,LTDS300-221002025-02-19
08800053094047S300 SeriesDENTIS CO. ,LTDS300-221012025-02-19
08800053094061S300 SeriesDENTIS CO. ,LTDS300-231002025-02-19
08800053094078S300 SeriesDENTIS CO. ,LTDS300-231012025-02-19
08800053094085S300 SeriesDENTIS CO. ,LTDS300-241002025-02-19
08800053094092S300 SeriesDENTIS CO. ,LTDS300-241012025-02-19
08800053094108S300 SeriesDENTIS CO. ,LTDS300-251002025-02-19
08800053094115S300 SeriesDENTIS CO. ,LTDS300-251012025-02-19
08800053094122S300 SeriesDENTIS CO. ,LTDS300-301002025-02-19
08800053094139S300 SeriesDENTIS CO. ,LTDS300-311002025-02-19
08800053094146S300 SeriesDENTIS CO. ,LTDS300-311012025-02-19
08800053094153S300 SeriesDENTIS CO. ,LTDS300-321002025-02-19
08800053094160S300 SereisDENTIS CO. ,LTDS300-321012025-02-19
08800053094184S300 SeriesDENTIS CO. ,LTDS300-361002025-02-19
08800053094191S300 SeriesDENTIS CO. ,LTDS300-361012025-02-19
08800053094214S300 SeriesDENTIS CO. ,LTDS300-371002025-02-19
08800053094221S300 SeriesDENTIS CO. ,LTDS300-371012025-02-19
08800053093743S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-250002024-10-30
08800053093644S250 Series(Ceiling, MobileDENTIS CO. ,LTDS250-200002024-10-29
08800053093651S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-210002024-10-29
08800053093668S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-210012024-10-29
08800053093675S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-220002024-10-29
08800053093682S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-220012024-10-29
08800053093705S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-230002024-10-29
08800053093712S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-230012024-10-29
08800053093729S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-240002024-10-29
08800053093736S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-240012024-10-29
08800053093750S250 Series(Ceiling, Mobile)DENTIS CO. ,LTDS250-250012024-10-29
01816835023898Vu-EMedical Illumination International Inc.NVSD3D3M1-E-LCH2022-12-09
00724995222710ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995222758ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995222864ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995222871ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995222895ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995222925ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995222932ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223007ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223021ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223038ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223045ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223052ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223083ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223106ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223120ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223137ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223151ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223175ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223182ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995223199ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995225728ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995225735ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
00724995225759ALYONSTERIS CORPORATIONALYON Surgical Lighting System2024-02-19
08800053060745S300 seriesDENTIS CO. ,LTDS300-A00002024-01-23
08800053060752S300 seriesDENTIS CO. ,LTDS300-A00102024-01-23
08800053062527M400 Series (Ceiling, Mobile)DENTIS CO. ,LTDM400-A00002024-01-23