SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK— 510(k) K030891

Substantially Equivalent

Surgistar, Inc.

FDA 510(k) clearance K030891 for SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK, Substantially Equivalent on 2003-06-17. Applicant: Surgistar, Inc..

Clearance details

Applicant: Surgistar, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2003-03-21
Decision date: 2003-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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.