Cleared Traditional

CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

K150590 · Contamac, Ltd. · Ophthalmic
Jul 2015
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K150590 is an FDA 510(k) clearance for the CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on July 10, 2015, 123 days after receiving the submission on March 9, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K150590 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date July 10, 2015
Days to Decision 123 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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