FDA.reportPublic FDA data

LUCEA LED®

Primary DI
03700712404710
Brand
LUCEA LED®
Company
MAQUET SAS
Model
ARDLCA506006A
Device description
LCA100 MOBILE UPGRADE
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FTDLamp, surgical
NTNLed light source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2
NTNLed Light SourceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113679000LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.2012-01-12NTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700712404710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700712404710037007124047103700712404710

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light standA mobile device designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. It is a mobile floor stand which may include wheels and/or articulated arms to enable dynamic positioning; the device to be supported (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264700139
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700712438524Maquet OrchideARD2019100012026-05-11
03700712434472Maquet OrchideARD5688039862026-05-06
03700712434489Maquet OrchideARD5692049452026-05-06
03700712432935Maquet EquipmentARDEQT639029A2023-12-15
03700712421489Maquet EquipmentARDSAT629009A2023-07-03
03700712422448Maquet EquipmentARDSAT629008A2023-07-03
03700712416829Maquet Equipment ARDSAT229007A2022-03-25
03700712401092NAARD515031140A2016-09-12
03700712401108NAARD515032140A2016-09-12
03700712435868Maquet EzeaARDEZA209012A2025-10-09
03700712438463VolistaARDVCS629116A2025-10-09
03700712438470VolistaARDVST629119A2025-10-09
03700712415969Maquet OrchideARD5688039512024-08-26
03700712418274Maquet OrchideARD5688039672022-03-04
03700712434526Maquet PowerLED IIARDPWT679119A2025-09-03
03700712435851Maquet PowerLED IIARDPWT679120A2025-09-03
03700712436063Maquet PowerLED IIARDPWT629160A2025-09-03
03700712436087Maquet PowerLED IIARDPWT609167A2025-09-03
03700712434540VolistaARDVCS629000A2025-06-05
03700712434557VolistaARDVCS629001A2025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
04547410513790FUJIFILMFUJIFILM CORPORATIONNTN2025-05-31
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
00850036790013AveliRevelle Aesthetics, Inc.FTD2024-02-26
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
03700712432423Maquet EzeaMAQUET SASFTD2024-01-10
03700712432430Maquet EzeaMAQUET SASFTD2024-01-10
03700712432461Maquet EzeaMAQUET SASFTD2024-01-10
03700712432478Maquet EzeaMAQUET SASFTD2024-01-10
03700712432737Maquet EzeaMAQUET SASFTD2024-01-10
03700712432928Maquet EzeaMAQUET SASFTD2024-01-10
04250480113530N/ASCHÖLLY FIBEROPTIC GmbHNTN2024-01-08
04250480113677EleVision™SCHÖLLY FIBEROPTIC GmbHNTN2024-01-08
08033638801048Pen LEDSAPI MED SPANTN2023-08-02
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-07-11
03700712430597Maquet PowerLED IIMAQUET SASFTD2023-07-05
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-06-26