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FDA 510(k)

ONE UP DISPOSABLE KERATOME HEAD

K-Number: K981742 · 1998-08-25

ApplicantMoria, Inc.
Decision Date1998-08-25
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ONE UP DISPOSABLE KERATOME HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Moria, Inc.. It received FDA 510(k) clearance on 1998-08-25 under 510(k) number K981742. 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 ONE UP DISPOSABLE KERATOME HEAD?

ONE UP DISPOSABLE KERATOME HEAD is a medical device that received FDA 510(k) clearance on 1998-08-25. The listed applicant is Moria, Inc.. The 510(k) number is K981742.

When did ONE UP DISPOSABLE KERATOME HEAD receive FDA 510(k) clearance?

ONE UP DISPOSABLE KERATOME HEAD received FDA 510(k) clearance on 1998-08-25, under 510(k) number K981742.

Who is the listed applicant for ONE UP DISPOSABLE KERATOME HEAD?

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

What is the FDA product code for ONE UP DISPOSABLE KERATOME HEAD?

The FDA product code for ONE UP DISPOSABLE KERATOME HEAD is HNO.

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Other records listing Moria, 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.

K003594CARRIAZO BARRAQUER SINGLE USE MICROKERATOMEK002191CARRIAZO BARRAQUER II MICROKERATOMEK981741CARRIAZO BARRAQUER 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.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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