SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR— 510(k) K033655

Substantially Equivalent

Soflex Contact Lens Industries , Ltd.

FDA 510(k) clearance K033655 for SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR, Substantially Equivalent on 2004-07-30. Applicant: Soflex Contact Lens Industries , Ltd..

Clearance details

Applicant: Soflex Contact Lens Industries , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2003-11-21
Decision date: 2004-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, 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.