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FDA 510(k)

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM

K-Number: K052891 · 2006-03-23

ApplicantHawken Industries
Decision Date2006-03-23
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hawken Industries. It received FDA 510(k) clearance on 2006-03-23 under 510(k) number K052891. 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 HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM?

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-23. The listed applicant is Hawken Industries. The 510(k) number is K052891.

When did HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM receive FDA 510(k) clearance?

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM received FDA 510(k) clearance on 2006-03-23, under 510(k) number K052891.

Who is the listed applicant for HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM?

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

What is the FDA product code for HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM?

The FDA product code for HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM is HNO.

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.

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Other records listing Hawken Industries 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.

K981155FLAPMAKER DISPOSABLE MICROKERATOME

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.K051486NORWOOD ABBEY CENTURION SES EPIKERATOMENorwood Abbey , Ltd.

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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