MICROKERATOME, MODEL MK-2000— 510(k) K990900

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K990900 for MICROKERATOME, MODEL MK-2000, Substantially Equivalent on 1999-09-24. Applicant: Nidek, Inc..

Clearance details

Applicant: Nidek, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1999-03-18
Decision date: 1999-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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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.