DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Sauflon Pharmaceuticals, Ltd.
Product code
Code MVN
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Twickenham, Middlesex, GB
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MVN

product code MVN
Injury
149
Total
149

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K130331

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130331.

Data sourced from openFDA. This site is unofficial and independent of the FDA.