FDA.reportPublic FDA data

ORA System® VerifEye™

Primary DI
00380657529995
Brand
ORA System® VerifEye™
Company
Alcon Laboratories, Inc.
Model
8065752999
Device description
ORA System with VerifEyeTM Lynk, Aberrometer 184.5
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00380657529995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380657529995003806575299953806575299950380657529995

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic refractometer, automatedAn electrically-powered, automated, ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina) by measuring how light is changed when it enters the patient's eye(s). A beam of light is emitted from the device into the patient's eye and reflected back out where it is detected and measured for sphere, cylinder and axis, as well as high order aberration measurements; typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information, the device, also known as an aberrometer, will automatically calculate the lens prescription needed to correct the patient's vision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

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
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
00860479001706Tracey-VFA Visual Function AnalyzerTRACEY TECHNOLOGIES, CORPORATIONNCF2020-01-09