OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES— 510(k) K013445

Substantially Equivalent

Florida Optical Engineering, Inc.

FDA 510(k) clearance K013445 for OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES, Substantially Equivalent on 2001-12-26. Applicant: Florida Optical Engineering, Inc..

Clearance details

Applicant: Florida Optical Engineering, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-10-17
Decision date: 2001-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

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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.