DIGNITY OPHTHALMIC SURGICAL SYSTEM— 510(k) K031404

Substantially Equivalent

Phacor Inc., A Santen Company

FDA 510(k) clearance K031404 for DIGNITY OPHTHALMIC SURGICAL SYSTEM, Substantially Equivalent on 2003-05-22. Applicant: Phacor Inc., A Santen Company.

Clearance details

Applicant: Phacor Inc., A Santen Company
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2003-05-05
Decision date: 2003-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.