Cleared Traditional

SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT

K133740 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic
Mar 2014
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K133740 is an FDA 510(k) clearance for the SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on March 5, 2014, 86 days after receiving the submission on December 9, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K133740 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2013
Decision Date March 05, 2014
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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