MODIFICATION TO VISITOME 20-10 MICROKERATOME— 510(k) K042083

Name: FDA 510(k) clearance K042083
Creator: U.S. Food and Drug Administration
Published: 2004-11-16

Substantially Equivalent

Biovision AG

FDA 510(k) clearance K042083 for MODIFICATION TO VISITOME 20-10 MICROKERATOME, Substantially Equivalent on 2004-11-16. Applicant: Biovision AG. Device class: 1.

Clearance details

Applicant: Biovision AG
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 2004-08-03
Decision date: 2004-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.