SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER— 510(k) K130342

Substantially Equivalent

Sauflon Pharmaceuticals, Ltd.

FDA 510(k) clearance K130342 for SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER, Substantially Equivalent on 2013-08-05. Applicant: Sauflon Pharmaceuticals, Ltd..

Clearance details

Applicant: Sauflon Pharmaceuticals, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2013-02-11
Decision date: 2013-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twickenham, Middlesex, GB

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.