FDA.reportPublic FDA data

OptiLux LED Illuminator

Primary DI
00816835024223
Brand
OptiLux LED Illuminator
Company
Medical Illumination International Inc.
Model
IL-2386 INTL
Device description
LED Illuminator, Portable, International
Published
2023-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HBIIlluminator, Fiberoptic, Surgical Field

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBIIlluminator, Fiberoptic, Surgical FieldGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163185000OptiLux LED IlluminatorIsolux, LLC2016-11-21HBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816835024222PackageGS11In Commercial Distribution
00816835024223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816835024222018168350242221816835024222
00816835024223008168350242238168350242230816835024223

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

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
00816835024384SYSTEM TWO LEDSD3CD3-CNE-LCH-4K2026-04-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419067Bausch + LombBausch & Lomb IncorporatedHBI2026-04-30
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2025-02-26
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-10-15
00816744027728NICO Myriad SPECTRANICO CORPORATIONHBI2024-06-07
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-06-07
00816835024216OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024230OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024247OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024215OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024222OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024239OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024246OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816744027704NICO Myriad NOVUSNICO CORPORATIONHBI2023-04-28
00857580006782Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2023-03-06
00857580006799Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2023-03-06
00851925007700Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007717Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007724Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007731Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007748Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007755Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007762Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007779Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
M678DPLS300W0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCHBI2022-02-25
00857580006775Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2021-10-20
00857580006768Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2021-03-18
00857580006751Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2021-02-18
00857580006713Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2019-03-04
00857580006706Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2018-09-20
00857580006690Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2018-07-30