Cleared Traditional

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

K160859 · Contamac, Ltd. · Ophthalmic
Jul 2016
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K160859 is an FDA 510(k) clearance for the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E), a Lens, Contact (orthokeratology) (Class II — Special Controls, product code MUW), submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on July 13, 2016, 106 days after receiving the submission on March 29, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K160859 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2016
Decision Date July 13, 2016
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MUW — Lens, Contact (orthokeratology)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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