FDA.reportPublic FDA data

Enova Illumination

Primary DI
00810186670221
Brand
Enova Illumination
Company
Enova Illumination, Inc.
Model
90096-XX3
Device description
Quest Premium LED Headlight SystemContains the following items, by Enova part number and UDI:Part Name Part No. UDIQuest Headlight 80099 00850025993968Carrying Case 80034-001 00850025993678PP4+ 80205-001 00850025993975PP4+ Cable 80305-001 00850025993982Battery Belt 80500-001 00850025993722Base Station 80100-001 00850025993647C-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
2026-03-31
Public version status
Update
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
00810186670221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810186670221008101866702218101866702210810186670221

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.

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
00810186670269Enova Illumination90095-0012026-04-08
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
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
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
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