Rescan 700

FDA 510(k) K233421 · Carl Zeiss Meditec, AG

Substantially Equivalent

510(k) numberK233421

Submission

Device name
Rescan 700
Applicant
Carl Zeiss Meditec, AG
Jena, DE
Received
October 10, 2023
Decision date
March 8, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBO – Tomography, Optical Coherence
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

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K261019AnterionOBO · Traditional Heidelberg Engineering GmbH09/11/2026SE
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K252633Unity DX (Udx)OBO · Traditional Cylite Pty. , Ltd.12/23/2025SE
K250553Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional Tomey Corporation07/18/2025SE
K250868SPECTRALIS HRA+OCT and variantsOBO · Traditional Heidelberg Engineering GmbH05/12/2025SE
K240924AnterionOBO · Traditional Heidelberg Engineering GmbH12/13/2024SE
K241163SPECTRALIS with Flex ModuleOBO · Traditional Heidelberg Engineering GmbH10/11/2024SE
K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional Topcon Corporation07/17/2024SE
K240221SPECTRALIS HRA+OCT and variantsOBO · Traditional Heidelberg Engineering GmbH07/01/2024SE
K233933CIRRUS™ HD-OCT Model 6000OBO · Traditional Carl Zeiss Meditec, Inc.05/17/2024SE

More from Carl Zeiss Meditec, Inc.

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K233911VISULAS combiHQF · Traditional 09/06/2024SE
K240215Blue 400; Blue 400 SQFX · Traditional 06/28/2024SE
K233933CIRRUS™ HD-OCT Model 6000OBO · Traditional 05/17/2024SE
K232944CALLISTO eyeNFJ · Special 12/21/2023SE
K232051VISULAS greenHQF · Traditional 10/24/2023SE
K230350VISULAS yagHQF · Traditional 09/22/2023SE
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Questions and answers

When was Rescan 700 cleared by the FDA?

Rescan 700 (K233421) received a 510(k) decision of Substantially Equivalent on March 8, 2024, 150 days after the submission was received.

What is the product code of K233421?

The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.