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FDA 510(k)

M3 MICROKERATOME

K-Number: K032836 · 2004-06-18

ApplicantMoria SA
Decision Date2004-06-18
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

M3 MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2004-06-18 under 510(k) number K032836. 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 M3 MICROKERATOME?

M3 MICROKERATOME is a medical device that received FDA 510(k) clearance on 2004-06-18. The listed applicant is Moria SA. The 510(k) number is K032836.

When did M3 MICROKERATOME receive FDA 510(k) clearance?

M3 MICROKERATOME received FDA 510(k) clearance on 2004-06-18, under 510(k) number K032836.

Who is the listed applicant for M3 MICROKERATOME?

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

What is the FDA product code for M3 MICROKERATOME?

The FDA product code for M3 MICROKERATOME 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 Moria SA 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.

K172994EPI K ConsoleK043183EPI-KK040297ONEUSE- PLUS MICROKERATOMEK022560M2 SINGLE USE MICROKERTOME

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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