SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR— 510(k) K020642

Substantially Equivalent

Soflex Contact Lens Industries , Ltd.

FDA 510(k) clearance K020642 for SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR, Substantially Equivalent on 2002-05-24. Applicant: Soflex Contact Lens Industries , Ltd..

Clearance details

Applicant: Soflex Contact Lens Industries , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2002-02-27
Decision date: 2002-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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.