ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS)— 510(k) K974599

Substantially Equivalent

Opti-Centre Laboratories

FDA 510(k) clearance K974599 for ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS), Substantially Equivalent on 1998-03-02. Applicant: Opti-Centre Laboratories.

Clearance details

Applicant: Opti-Centre Laboratories
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1997-12-09
Decision date: 1998-03-02
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.