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FDA 510(k)

CENTURION SES EPIKERATOME

K-Number: K031735 · 2003-08-21

ApplicantCiba Vision Corporation
Decision Date2003-08-21
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CENTURION SES EPIKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Vision Corporation. It received FDA 510(k) clearance on 2003-08-21 under 510(k) number K031735. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTURION SES EPIKERATOME?

CENTURION SES EPIKERATOME is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Ciba Vision Corporation. The 510(k) number is K031735.

When did CENTURION SES EPIKERATOME receive FDA 510(k) clearance?

CENTURION SES EPIKERATOME received FDA 510(k) clearance on 2003-08-21, under 510(k) number K031735.

Who is the listed applicant for CENTURION SES EPIKERATOME?

The FDA 510(k) record lists Ciba Vision Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTURION SES EPIKERATOME?

The FDA product code for CENTURION SES EPIKERATOME is HNO.

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Other records listing Ciba Vision Corporation 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.

K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCALK113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORICK083216CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSESK073459CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSESK072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSESK062262CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

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Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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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