SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES— 510(k) K060821

Substantially Equivalent

Specialeyes, LLC

FDA 510(k) clearance K060821 for SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES, Substantially Equivalent on 2006-05-18. Applicant: Specialeyes, LLC.

Clearance details

Applicant: Specialeyes, LLC
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2006-03-27
Decision date: 2006-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

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.