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IOLMaster 700

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
IOLMaster 700 FDA UDI
Generic Name
Optical low coherence reflectometry (OLCR) biometer FDA UDI
Device Name
The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: • Lens thickness • Corneal curvature and thickness • Axial length • Anterior chamber depth • Pupil diameter • White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. FDA UDI
Model / Reference
IOLMaster 700 FDA UDI
Description
The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: • Lens thickness • Corneal curvature and thickness • Axial length • Anterior chamber depth • Pupil diameter • White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. FDA UDI

Identifiers

Primary DI / UDI-DI
04049471092080 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

Category: Optical low coherence reflectometry (OLCR) biometer

IOLMaster 700 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.

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 903bbe97-cae5-401b-8467-a67b8f12a760 35 fields · synced May 30, 2026