ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS— 510(k) K001144

Name: FDA 510(k) clearance K001144
Creator: U.S. Food and Drug Administration
Published: 2000-05-05

Substantially Equivalent

Lasersight Technologies, Inc.

FDA 510(k) clearance K001144 for ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS, Substantially Equivalent on 2000-05-05. Applicant: Lasersight Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Lasersight Technologies, Inc.
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 2000-04-10
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, 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.