FDA.reportPublic FDA data

WaveDyn

Primary DI
10860009562803
Brand
WaveDyn
Company
Wavefront Dynamics Inc.
Model
WVA260
Catalog number
WVA260
Published
2023-03-17
Public version status
New
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
10860009562803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086000956280310860009562803

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
505-221-5946support@wavdyn.com

Regulatory Flags#

DUNS number
117570836
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
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
00860479001706Tracey-VFA Visual Function AnalyzerTRACEY TECHNOLOGIES, CORPORATIONNCF2020-01-09