LL BI-FOCAL, DAILY WEAR CONTACT LENS— 510(k) K971647

Substantially Equivalent

Lombart Lenses, Ltd.

FDA 510(k) clearance K971647 for LL BI-FOCAL, DAILY WEAR CONTACT LENS, Substantially Equivalent on 1997-07-15. Applicant: Lombart Lenses, Ltd..

Clearance details

Applicant: Lombart Lenses, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1997-05-05
Decision date: 1997-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norfolk, VA, 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.