FDA.reportPublic FDA data

IOLMaster 500

Primary DI
04049471092066
Brand
IOLMaster 500
Company
Carl Zeiss Meditec AG
Model
IOLMaster 500
Device description
The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
Published
2016-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122418000
K141068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122418000IOLMASTER 500Carl Zeiss Meditec, AG2013-04-12HJO
K141068000ZEISS CATARACT SUITE MARKERLESSCarl Zeiss Meditec, AG2014-09-09HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049471092066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049471092066040494710920664049471092066

GMDN Terms#

Term, Definition table
TermDefinition
Optical low coherence reflectometry (OLCR) biometerA mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Weight18Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314594680
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14

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