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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 the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2019-06-25 under 510(k) 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. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K191194.

When did CLARUS receive FDA 510(k) clearance?

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

Who is the listed applicant for CLARUS?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARUS?

The FDA product code for CLARUS is QER.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05646004621 Real World StudyCOMPLETEDNCT05729477A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System DeviceTERMINATEDNCT06111222Visual Performance of Patients Implanted With a Multifocal IOLCOMPLETEDNCT06264232AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract RemovalCOMPLETEDNCT06428955Evaluation of a Monofocal Intraocular LensCOMPLETEDNCT07092020Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)COMPLETED

Other records listing Carl Zeiss Meditec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260694ZEISS CLINIC 360PMA P060004Excimer laser systemPMA P150040Femtosecond laser system for refractive correctionK243878CLARUS (700)K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)K233911VISULAS combi

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Related Devices (Code: QER)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243878CLARUS (700)Carl 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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