AUTOMATED DISPOSABLE KERATOME (ADK)— 510(k) K974004

Substantially Equivalent

Lasersight Technologies, Inc.

FDA 510(k) clearance K974004 for AUTOMATED DISPOSABLE KERATOME (ADK), Substantially Equivalent on 1998-01-08. Applicant: Lasersight Technologies, Inc..

Clearance details

Applicant: Lasersight Technologies, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1997-10-21
Decision date: 1998-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.