FDA.reportPublic FDA data

HD Analyzer

Primary DI
18437014903024
Brand
HD Analyzer
Company
VISIOMETRICS SL
Model
.OQAS
Catalog number
.OQAS
Device description
HD Analyzer Optical Quality Analysis System
Published
2022-01-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NCFAberrometer, ophthalmic
PJZCamera, ophthalmic, general-use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCFAberrometer, OphthalmicOphthalmic1
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18437014903024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1843701490302418437014903024

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+34937429147technicalservice@visiometrics.com
+34935824501technicalservice@visiometrics.com

Regulatory Flags#

DUNS number
465168057
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18437014903031TearFilm Analyzer0010012022-01-21

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Primary DI, Brand, Company table
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07908616100042EyerPHELCOM TECHNOLOGIES SAPJZ2023-04-27
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10860009562803WaveDynWavefront Dynamics Inc.NCF2023-03-17
00811608013770Volk VistaViewVOLK OPTICAL INC.PJZ2022-11-16
00850038195229Eli EzerU.S. OPHTHALMIC, L.L.C.PJZ2022-11-03
06945087500088MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.PJZ2022-11-02
00628678036017WRI-1Cellview Imaging Inc.PJZ2022-09-08