BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T— 510(k) K011316

Substantially Equivalent

American Contact Lens, Inc.

FDA 510(k) clearance K011316 for BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T, Substantially Equivalent on 2001-06-13. Applicant: American Contact Lens, Inc..

Clearance details

Applicant: American Contact Lens, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-04-30
Decision date: 2001-06-13
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.