FDA.reportPublic FDA data

Enova Illumination

Primary DI
00810186670269
Brand
Enova Illumination
Company
Enova Illumination, Inc.
Model
90095-001
Device description
Quantum Warm Standard LED Headlight SystemContains the following items, by Enova part number and UDI:Part Name Part No. UDIQuantum Warm lamp 80085 00850025993579Carrying Case 80034-001 00850025993678PP4 80201-001 00850025993616Gray Twist Cable 80302-001 00850025993692Battery Belt 80500-001 00850025993722Single Charger 80101-001 00850025993623C-13 Power Cord (Type B)* 80150-001 00850025993739C-13 Power Cord (Type C)* 80150-00C 00810186670214C-13 Power Cord (Type G)* 80150-00G 00810186670139C-13 Power Cord (Type I)* 80150-00I 00810186670207*One power cord per system; style depends on region to which the unit is sold.
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810186670269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810186670269008101866702698101866702690810186670269

GMDN Terms#

Term, Definition table
TermDefinition
Headband, reusableA device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device.

Regulatory Flags#

DUNS number
080805136
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810186670238Enova Illumination90096-XX12026-04-08
00810186670245Enova Illumination90094-0012026-04-08
00810186670252Enova Illumination90094-0032026-04-08
00810186670276Enova Illumination90095-0032026-04-08
00810186670283Enova Illumination90092-0012026-04-08
00810186670290Enova Illumination90092-0022026-04-08
00810186670306Enova Illumination90092-0032026-04-08
00810186670313Enova Illumination90092-0042026-04-08
00810186670320Enova Illumination90093-0012026-04-08
00810186670337Enova Illumination90093-0022026-04-08
00810186670344Enova Illumination90093-0032026-04-08
00810186670351Enova Illumination90093-0042026-04-08
00810186670368Enova Illumination90097-0012026-04-08
00810186670375Enova Illumination90097-0022026-04-08
00810186670382Enova Illumination90097-0032026-04-08
00810186670399Enova Illumination90097-0042026-04-08
00810186670221Enova Illumination90096-XX32026-03-31
00810186670214Enova Illumination80150-00C2026-02-27
00810186670146Enova Illumination80801-0012025-12-10
00810186670153Enova Illumination80801-0022025-12-10

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
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
00840277411099MedLED SpectraRIVERPOINT MEDICAL, LLCHPP2025-10-28