Cleared Traditional

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

K171575 · Contamac, Ltd. · Ophthalmic
Oct 2017
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K171575 is an FDA 510(k) clearance for the ENFLU 18 (enflufocon A) Daily Wear Contact Lens, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on October 24, 2017, 147 days after receiving the submission on May 30, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K171575 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2017
Decision Date October 24, 2017
Days to Decision 147 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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