SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)— 510(k) K003526

Substantially Equivalent

Specialty Ultravision, Inc.

FDA 510(k) clearance K003526 for SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON), Substantially Equivalent on 2001-02-12. Applicant: Specialty Ultravision, Inc..

Clearance details

Applicant: Specialty Ultravision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2000-11-16
Decision date: 2001-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campbell, CA, 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.