FDA.reportPublic FDA data

Enova Illumination

Primary DI
00810186670146
Brand
Enova Illumination
Company
Enova Illumination, Inc.
Model
80801-001
Device description
Atom Wireless Light, Gen II
Published
2025-12-10
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
00810186670146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810186670146008101866701468101866701460810186670146

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, battery-poweredA battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080805136
Device count
1
DM exempt
true
Premarket exempt
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
00810186670221Enova Illumination90096-XX32026-03-31
00810186670214Enova Illumination80150-00C2026-02-27
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
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
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