RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T— 510(k) K983496

Substantially Equivalent

Opti-Centre Laboratories

FDA 510(k) clearance K983496 for RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T, Substantially Equivalent on 1999-03-29. Applicant: Opti-Centre Laboratories.

Clearance details

Applicant: Opti-Centre Laboratories
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-10-05
Decision date: 1999-03-29
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.