510(k) K180985— Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

Substantially Equivalent

Supervision Optimax Sdn Bhd

Clearance details

Applicant: Supervision Optimax Sdn Bhd
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2018-04-13
Decision date: 2018-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungai Buloh, MY

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.