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FDA 510(k)

CLARUS (700)

K-Number: K243878 · 2025-04-17

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2025-04-17
Product CodeQER
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLARUS (700) is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2025-04-17 under approval number K243878. The device is classified under product code QER. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS (700)?

CLARUS (700) is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K243878.

When was CLARUS (700) approved by the FDA?

CLARUS (700) received FDA 510(k) clearance on 2025-04-17, under approval number K243878.

What company makes CLARUS (700)?

CLARUS (700) is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for CLARUS (700)?

The FDA product code for CLARUS (700) is QER.

Other Devices by Carl Zeiss Meditec, Inc.

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Related Devices (Code: QER)

K191194CLARUSCarl Zeiss Meditec, Inc. K181444CLARUSCarl Zeiss Meditec, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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