Cleared Traditional

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

K130331 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic
Jul 2013
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K130331 is an FDA 510(k) clearance for the SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER, a Lens, Contact, (disposable) (Class II — Special Controls, product code MVN), submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on July 26, 2013, 165 days after receiving the submission on February 11, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K130331 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2013
Decision Date July 26, 2013
Days to Decision 165 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MVN — Lens, Contact, (disposable)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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