POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR— 510(k) K080794

Substantially Equivalent

Polyvue Distribution, Inc.

FDA 510(k) clearance K080794 for POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, Substantially Equivalent on 2008-12-17. Applicant: Polyvue Distribution, Inc..

Clearance details

Applicant: Polyvue Distribution, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2008-03-20
Decision date: 2008-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Felton, 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.