S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-— 510(k) K001962

Substantially Equivalent

Bescon Co., Ltd.

FDA 510(k) clearance K001962 for S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-, Substantially Equivalent on 2001-07-09. Applicant: Bescon Co., Ltd..

Clearance details

Applicant: Bescon Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2000-06-27
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, 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.