BLADEWORKS MICROKERATOME BLADE, MODEL 7061— 510(k) K020079

Name: FDA 510(k) clearance K020079
Creator: U.S. Food and Drug Administration
Published: 2002-04-19

Substantially Equivalent

Blade Works, Inc.

FDA 510(k) clearance K020079 for BLADEWORKS MICROKERATOME BLADE, MODEL 7061, Substantially Equivalent on 2002-04-19. Applicant: Blade Works, Inc.. Device class: 1.

Clearance details

Applicant: Blade Works, Inc.
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 2002-01-10
Decision date: 2002-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, 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.