KRATZ NOVA SERT(TM)— 510(k) K883489

Substantially Equivalent

Coopervision-Cilco

FDA 510(k) clearance K883489 for KRATZ NOVA SERT(TM), Substantially Equivalent on 1988-10-25. Applicant: Coopervision-Cilco.

Clearance details

Applicant: Coopervision-Cilco
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1988-08-16
Decision date: 1988-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, 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.