SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K013649

Substantially Equivalent

Sauflon Pharmaceuticals, Ltd.

FDA 510(k) clearance K013649 for SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2001-12-26. Applicant: Sauflon Pharmaceuticals, Ltd..

Clearance details

Applicant: Sauflon Pharmaceuticals, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-11-05
Decision date: 2001-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twickenham, Middlesex, GB

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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.