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IOLMaster 500

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
IOLMaster 500 FDA UDI
Generic Name
Optical low coherence reflectometry (OLCR) biometer FDA UDI
Device Name
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. FDA UDI
Model / Reference
IOLMaster 500 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04049471092066 FDA UDI
510(k) Number
K122418 FDA UDI
K141068 FDA UDI
FDA Product Code
HJO FDA UDI
GMDN Term
Optical low coherence reflectometry (OLCR) biometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 18 Kilogram FDA UDI

Category: Optical low coherence reflectometry (OLCR) biometer

IOLMaster 500 by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical low coherence reflectometry (OLCR) biometer.

Cleared under the same submission

K141068 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carl Zeiss Meditec AG

Sources (1)

  • FDA UDI 425adeb8-2247-4540-ae7b-34689590357b 36 fields · synced May 30, 2026