COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K011893

Substantially Equivalent

Contact Color Srl

FDA 510(k) clearance K011893 for COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 2001-12-06. Applicant: Contact Color Srl.

Clearance details

Applicant: Contact Color Srl
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-06-18
Decision date: 2001-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

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.