OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S— 510(k) K011577

Substantially Equivalent

Ocu-Ease Optical Products, Inc.

FDA 510(k) clearance K011577 for OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S, Substantially Equivalent on 2001-06-19. Applicant: Ocu-Ease Optical Products, Inc..

Clearance details

Applicant: Ocu-Ease Optical Products, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-05-22
Decision date: 2001-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinole, CA, 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.