HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM— 510(k) K052891

Substantially Equivalent

Hawken Industries

FDA 510(k) clearance K052891 for HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM, Substantially Equivalent on 2006-03-23. Applicant: Hawken Industries.

Clearance details

Applicant: Hawken Industries
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2005-10-13
Decision date: 2006-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, 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.