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
03700712436124VolistaARDVCS209058A2026-07-20
03700712436131VolistaARDVCS209059A2026-07-20
03700712436148VolistaARDVCS209060A2026-07-20
03700712436155VolistaARDVCS209061A2026-07-20
03700712436162VolistaARDVCS209062A2026-07-20
03700712436179VolistaARDVCS209063A2026-07-20
03700712436186VolistaARDVCS209064A2026-07-20
03700712436193VolistaARDVCS209065A2026-07-20
03700712436209VolistaARDVCS209066A2026-07-20
03700712436216VolistaARDVCS209067A2026-07-20
03700712436223VolistaARDVCS209068A2026-07-20
03700712436230VolistaARDVCS209069A2026-07-20
03700712436247VolistaARDVCS209070A2026-07-20
03700712436254VolistaARDVCS209071A2026-07-20
03700712436261VolistaARDVCS209072A2026-07-20
03700712436278VolistaARDVCS209073A2026-07-20
03700712436285VolistaARDVCS209074A2026-07-20
03700712436292VolistaARDVCS209075A2026-07-20
03700712436308VolistaARDVCS209076A2026-07-20
03700712436315VolistaARDVCS209077A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850009233049BihlerMedBihlerMed, L.L.C.FTD2026-07-24
10850009233056BihlerMedBihlerMed, L.L.C.FTD2026-07-24
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
06973786290078lmaging Processor System (lncluding Light Source)Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)NTN2023-07-26
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
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-06-26
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFTD2023-05-29
00816744027643NICO Myriad-LXNICO CORPORATIONFTD2023-04-26