DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT— 510(k) K954603

Substantially Equivalent

Wesley Jessen Corp.

FDA 510(k) clearance K954603 for DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT, Substantially Equivalent on 1996-01-04. Applicant: Wesley Jessen Corp..

Clearance details

Applicant: Wesley Jessen Corp.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1995-10-04
Decision date: 1996-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, 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.