PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K994335

Substantially Equivalent

Wesley Jessen Corp.

FDA 510(k) clearance K994335 for PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2000-03-20. Applicant: Wesley Jessen Corp..

Clearance details

Applicant: Wesley Jessen Corp.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1999-12-23
Decision date: 2000-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, 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.