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CIRRUS™ HD-OCT Model 6000

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K233933Ref 2660021173109, 2660021184767, 2660021187327Model 500, 5000, 6000

by Carl Zeiss Meditec, Inc.

Identity

Trade Name
CIRRUS HD-OCT Model 6000 EUDAMED
CIRRUS HD-OCT FDA UDI
Generic Name
Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Device Name
CIRRUS HD-OCT EUDAMED
The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. FDA UDI
Model / Reference
500, 5000, 6000 EUDAMED
2660021173109, 2660021184767, 2660021187327 EUDAMED
6000 FDA UDI
Description
The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. FDA UDI

Identifiers

Primary DI / UDI-DI
04057748087141 EUDAMEDFDA UDI
Basic UDI-DI
4057748_CIR001_6S EUDAMED
Direct Marketing DI
04057748087141 EUDAMED
510(k) Number
K233933 FDA 510(k)
FDA Product Code
OBO FDA 510(k)FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Ophthalmic spectral-domain optical coherence tomography system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 886.1570 FDA 510(k)
Regulation Number
886.1570 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

CIRRUS™ HD-OCT Model 6000 by Carl Zeiss Meditec, Inc. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Carl Zeiss Meditec, Inc.

Sources (4)

  • FDA 510(k) K233933 24 fields · synced Oct 6, 2026
  • FDA UDI dbae982e-d19d-44e1-8b1c-857a398c99f1 33 fields · synced May 30, 2026
  • EUDAMED 146c968b-ec42-47cb-9b20-e02c9c922891-1 61 fields · synced Sep 18, 2026
  • EUDAMED 146c968b-ec42-47cb-9b20-e02c9c922891-2 61 fields · synced Sep 18, 2026