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FDA 510(k)

BLADEWORKS MICROKERATOME BLADE

K-Number: K993225 · 2000-03-20

ApplicantBlade Works, Inc.
Decision Date2000-03-20
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLADEWORKS MICROKERATOME BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Blade Works, Inc.. It received FDA 510(k) clearance on 2000-03-20 under 510(k) number K993225. 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 BLADEWORKS MICROKERATOME BLADE?

BLADEWORKS MICROKERATOME BLADE is a medical device that received FDA 510(k) clearance on 2000-03-20. The listed applicant is Blade Works, Inc.. The 510(k) number is K993225.

When did BLADEWORKS MICROKERATOME BLADE receive FDA 510(k) clearance?

BLADEWORKS MICROKERATOME BLADE received FDA 510(k) clearance on 2000-03-20, under 510(k) number K993225.

Who is the listed applicant for BLADEWORKS MICROKERATOME BLADE?

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

What is the FDA product code for BLADEWORKS MICROKERATOME BLADE?

The FDA product code for BLADEWORKS MICROKERATOME BLADE 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 Blade Works, 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.

K020079BLADEWORKS MICROKERATOME BLADE, MODEL 7061K993591BLADEWORKS DISPOSABLE ALK TUBING

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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