Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VISTITOME 20-10 MICROKERATOME

K-Number: K014000 · 2002-03-11

ApplicantBiovision AG
Decision Date2002-03-11
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISTITOME 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 2002-03-11 under 510(k) number K014000. 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 VISTITOME 20-10 MICROKERATOME?

VISTITOME 20-10 MICROKERATOME is a medical device that received FDA 510(k) clearance on 2002-03-11. The listed applicant is Biovision AG. The 510(k) number is K014000.

When did VISTITOME 20-10 MICROKERATOME receive FDA 510(k) clearance?

VISTITOME 20-10 MICROKERATOME received FDA 510(k) clearance on 2002-03-11, under 510(k) number K014000.

Who is the listed applicant for VISTITOME 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 VISTITOME 20-10 MICROKERATOME?

The FDA product code for VISTITOME 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K042083MODIFICATION TO VISITOME 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

View on FDA Database →

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

↑