FDA.reportPublic FDA data

IOL-Station

Primary DI
04987669200780
Brand
IOL-Station
Company
NIDEK CO.,LTD.
Model
1.21
Device description
The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669200780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669200780049876692007804987669200780

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

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100301Endophotocoagulation delivery unit17118-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373012SoftPathSCC SOFT COMPUTERJQP2026-05-29
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04