MAZZOCCO/FRENCHIK FOLDER— 510(k) K860148

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K860148 for MAZZOCCO/FRENCHIK FOLDER, Substantially Equivalent on 1986-03-21. Applicant: Staar Surgical Co..

Clearance details

Applicant: Staar Surgical Co.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1986-01-15
Decision date: 1986-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.