FDA.reportPublic FDA data

IsoLED Plus+ LED HL

Primary DI
01816835024017
Brand
IsoLED Plus+ LED HL
Company
Medical Illumination International Inc.
Model
IL-2410
Device description
IsoLED Plus+ LED HL, Standard
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FCTHeadlight, Fiberoptic Focusing
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816835024017PackageGS11In Commercial Distribution
00816835024018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816835024017018168350240171816835024017
00816835024018008168350240188168350240180816835024018

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093357739
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810186670238Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670245Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670252Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670269Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670276Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670283Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670290Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670306Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670313Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670320Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670337Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670344Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670351Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670368Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670375Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670382Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670399Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670221Enova IlluminationEnova Illumination, Inc.HPP2026-03-31
08057147028963LYNXUNIVET LOUPES SPAHPP2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPAHPP2026-03-02
00810186670214Enova IlluminationEnova Illumination, Inc.HPP2026-02-27
00860015454782RocotoRocoto Inc.HPP2026-02-26
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00840277411082MedLED SpectraRIVERPOINT MEDICAL, LLCHPP2025-10-28