ZYOPTIX XP MICROKERATOME— 510(k) K040204

Substantially Equivalent

Bausch & Lomb, Inc.

FDA 510(k) clearance K040204 for ZYOPTIX XP MICROKERATOME, Substantially Equivalent on 2004-03-22. Applicant: Bausch & Lomb, Inc..

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2004-01-29
Decision date: 2004-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, 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.