FDA.reportPublic FDA data

Tracey-VFA Visual Function Analyzer

Primary DI
00860479001706
Brand
Tracey-VFA Visual Function Analyzer
Company
TRACEY TECHNOLOGIES, CORPORATION
Model
iTrace
Catalog number
Z2000
Device description
The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
Published
2020-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NCFAberrometer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCFAberrometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860479001706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860479001706008604790017068604790017060860479001706

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography systemAn assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
027572366
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380659983290ORA System® VerifEye™Alcon Laboratories, Inc.NCF2025-12-01
00380659983306ORA System® VerifEye™Alcon Laboratories, Inc.NCF2025-12-01
10860009562803WaveDynWavefront Dynamics Inc.NCF2023-03-17
18437014903024HD AnalyzerVISIOMETRICS SLNCF2022-01-21
18437014903031TearFilm AnalyzerVISIOMETRICS SLNCF2022-01-21
00380657529995ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530007ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530014ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530038ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530939ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380659983283ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31