Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLARUS

K-Number: K191194 · 2019-06-25

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2019-06-25
Product CodeQER
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLARUS is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2019-06-25 under approval number K191194. 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?

CLARUS is a medical device that received FDA 510(k) clearance on 2019-06-25. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K191194.

When was CLARUS approved by the FDA?

CLARUS received FDA 510(k) clearance on 2019-06-25, under approval number K191194.

What company makes CLARUS?

CLARUS is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for CLARUS?

The FDA product code for CLARUS is QER.

Other Devices by Carl Zeiss Meditec, Inc.

K161194PLEX Elite 9000 SS-OCT K182318Retina Workplace K173371VisuMax Femtosecond Laser K181534CIRRUS HD-OCT K181444CLARUS K230350VISULAS yag

View all 13 devices →

Related Devices (Code: QER)

K181444CLARUSCarl Zeiss Meditec, Inc. K243878CLARUS (700)Carl 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.

↑