BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES— 510(k) K994125

Substantially Equivalent

Bausch & Lomb, Inc.

FDA 510(k) clearance K994125 for BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES, Substantially Equivalent on 2000-03-03. Applicant: Bausch & Lomb, Inc..

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1999-12-07
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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.