Optixon 1-Day— 510(k) K201013

Substantially Equivalent

Optixon, Inc.

FDA 510(k) clearance K201013 for Optixon 1-Day, Substantially Equivalent on 2020-09-18. Applicant: Optixon, Inc..

Clearance details

Applicant: Optixon, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2020-04-17
Decision date: 2020-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.