SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER— 510(k) K130331

Substantially Equivalent

Sauflon Pharmaceuticals, Ltd.

FDA 510(k) clearance K130331 for SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER, Substantially Equivalent on 2013-07-26. Applicant: Sauflon Pharmaceuticals, Ltd..

Clearance details

Applicant: Sauflon Pharmaceuticals, Ltd.
Product code: Code MVN
Advisory panel: Ophthalmic
Date received: 2013-02-11
Decision date: 2013-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twickenham, Middlesex, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code MVN

product code MVN

Injury: 149
Total: 149

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.