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FDA 510(k)

MODIFICATION TO VISITOME 20-10 MICROKERATOME

K-Number: K042083 · 2004-11-16

ApplicantBiovision AG
Decision Date2004-11-16
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VISITOME 20-10 MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Biovision AG. It received FDA 510(k) clearance on 2004-11-16 under 510(k) number K042083. 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 MODIFICATION TO VISITOME 20-10 MICROKERATOME?

MODIFICATION TO VISITOME 20-10 MICROKERATOME is a medical device that received FDA 510(k) clearance on 2004-11-16. The listed applicant is Biovision AG. The 510(k) number is K042083.

When did MODIFICATION TO VISITOME 20-10 MICROKERATOME receive FDA 510(k) clearance?

MODIFICATION TO VISITOME 20-10 MICROKERATOME received FDA 510(k) clearance on 2004-11-16, under 510(k) number K042083.

Who is the listed applicant for MODIFICATION TO VISITOME 20-10 MICROKERATOME?

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

What is the FDA product code for MODIFICATION TO VISITOME 20-10 MICROKERATOME?

The FDA product code for MODIFICATION TO VISITOME 20-10 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 Biovision AG 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.

K014000VISTITOME 20-10 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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