FDA.reportPublic FDA data

SYSTEM TWO LED

Primary DI
00816835024384
Brand
SYSTEM TWO LED
Company
Medical Illumination International Inc.
Model
SD3CD3-CNE-LCH-4K
Device description
SYSTEM TWO D3, DUO, IL-CR &D3, ADJ CCT, 6G-SDI 4K
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSTLight, Surgical, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K10038800021ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSMedical Illumination International, Inc.2010-06-22FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816835024383PackageGS11In Commercial Distribution
00816835024384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816835024383018168350243831816835024383
00816835024384008168350243848168350243840816835024384

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure 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]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Regulatory Flags#

DUNS number
093357739
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816835024391SYSTEM TWO LEDSD3CD3-CNE-4K2026-04-30
00816835024407SYSTEM TWO LEDSD2CD2M1-LCH-4K2026-04-30
00816835024414SYSTEM TWO LEDSD3CDEM1-CNE-4K2026-04-30
00816835024421SYSTEM TWO LEDSD2C-LCH-4K2026-04-30
00816835024438SYSTEM TWO LEDSD3CD3M1M1-LCH-4K2026-04-30
00816835024445SYSTEM TWO LEDSD2CD2-4K2026-04-30
00816835024452SYSTEM TWO LEDSD2CD2-LCH-4K2026-04-30
00816835024469SYSTEM TWO LEDSD2CM1-LCH-4K2026-04-30
00816835024476SYSTEM TWO LEDSD3C-CNE-4K2026-04-30
00816835024483SYSTEM TWO LEDSD3CM1-CNE-LCH-4K2026-04-30
00816835023813VIDASHIELD/UV24071214/VS02D2022-12-16
01816835023812VIDASHIELD/UV24071214/VS02D2022-12-16
00816835024360Vu160NVSD3D3M1-LCH2025-02-19
00816835024353Vu160NVSD3M1-LCH2025-02-19
01816835024369Vu160NVSD3D3M1-LCH2025-02-19
00816835020409Vistor PRO LEDNV061513B2016-09-23
00816835024346SM1SM12024-09-04
01816835024345SM1SM12024-09-04
00816835024322MI-1000CAM061524CAM2024-08-19
00816835024339MI-1000CAM061525CAM2024-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816835024391SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024407SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024414SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024421SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024438SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024445SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024452SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024469SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024476SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024483SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
10845854040379CONMEDConmed CorporationFST2026-03-24
00816744020118NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021139NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021313NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021337NICO MyriadNICO CORPORATIONFST2025-07-30
00816835024360Vu160Medical Illumination International Inc.FST2025-02-19
00816835024353Vu160Medical Illumination International Inc.FST2025-02-19
01816835024369Vu160Medical Illumination International Inc.FST2025-02-19
00816744020095NICO MyriadNICO CORPORATIONFST2024-11-13
00816744020101NICO MyriadNICO CORPORATIONFST2024-11-13
00816835024346SM1Medical Illumination International Inc.FST2024-09-04
01816835024345SM1Medical Illumination International Inc.FST2024-09-04
00816835024322MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00816835024339MI-1000CAMMedical Illumination International Inc.FST2024-08-19
01816835024321MI-1000CAMMedical Illumination International Inc.FST2024-08-19
01816835024338MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00840606184922Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
00840606184946Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
00816744027728NICO Myriad SPECTRANICO CORPORATIONFST2024-06-07
00816835024315SYSTEM TWO LEDMedical Illumination International Inc.FST2024-01-18