Cleared Traditional

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens

K163254 · Acuity Polymers, Inc. · Ophthalmic
Jan 2017
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K163254 is an FDA 510(k) clearance for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Acuity Polymers, Inc. (Rochester, US). The FDA issued a Cleared decision on January 18, 2017, 58 days after receiving the submission on November 21, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K163254 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2016
Decision Date January 18, 2017
Days to Decision 58 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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