Cleared Traditional

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS

K013649 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic
Dec 2001
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K013649 is an FDA 510(k) clearance for the SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS, 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 December 26, 2001, 51 days after receiving the submission on November 5, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K013649 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2001
Decision Date December 26, 2001
Days to Decision 51 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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