FDA.reportPublic FDA data

VorOtek LED HeadLight

Primary DI
09348227000290
Brand
VorOtek LED HeadLight
Company
VOROTEK PTY LTD
Model
VLHH-D
Catalog number
VLHH-D
Device description
VorOtek LED HeadLight Fixed Spot - HeadBand. Fully Portable Surgical Quality Dimmable LED Illumination with Fixed Spot Size. Includes Power Pack, Charger & Carry Case.
Published
2023-08-08
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
09348227000290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348227000290093482270002909348227000290

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
744332997
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348227002164VorOtek SpeculumsVPS-B50-LVPS-B50-L2023-09-08
09348227002171VorOtek SpeculumsVPS-B50-MVPS-B50-M2023-09-08
09348227002188VorOtek SpeculumsVPS-B50-SVPS-B50-S2023-09-08
09348227002195VorOtek SpeculumsVPS-B50-XLVPS-B50-XL2023-09-08
09348227002201VorOtek SpeculumsVPS-B50-XSVPS-B50-XS2023-09-08
09348227000016VorOtek O ScopeVSOS-2DVSOS-2D2023-08-09
09348227000023VorOtek O ScopeVSOH-2DVSOH-2D2023-08-09
09348227000092VorOtek L ScopeVSLH-2.5 LVSLH-2.5 L2023-08-09
09348227000108VorOtek L ScopeVSLH-2.5 MVSLH-2.5 M2023-08-09
09348227000160VorOtek M ScopeVSMSVSMS2023-08-09
09348227001181VorOtek X-Series HeadlightVLHH-DAVLHH-DA2023-08-09
09348227001938VorOtek O ScopeVSOH-3DVSOH-3D2023-08-09
09348227002089VorOtek O ScopeVSOS-3DVSOS-3D2023-08-09
09348227000153VorOtek M ScopeVSMHVSMH2023-08-08
09348227000139VorOtek L ScopeVSLS-2.5 MVSLS-2.5 M2023-07-24
09348227000122VorOtek L ScopeVSLS-2.5 LVSLS-2.5 L2023-07-18

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