SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)— 510(k) K011542

Substantially Equivalent

Specialty Ultravision, Inc.

FDA 510(k) clearance K011542 for SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D), Substantially Equivalent on 2001-06-26. Applicant: Specialty Ultravision, Inc..

Clearance details

Applicant: Specialty Ultravision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-05-18
Decision date: 2001-06-26
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.