510(k) K181656— ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

Substantially Equivalent

Eyemed Technologies S.R.L.

Clearance details

Applicant: Eyemed Technologies S.R.L.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2018-06-22
Decision date: 2019-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Casorate Sempione, IT

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.