STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT— 510(k) K851936

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K851936 for STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT, Substantially Equivalent on 1985-08-20. Applicant: Staar Surgical Co..

Clearance details

Applicant: Staar Surgical Co.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1985-05-06
Decision date: 1985-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.