Cleared Traditional

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

K161100 · Contamac, Ltd. · Ophthalmic
Aug 2016
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K161100 is an FDA 510(k) clearance for the Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses, 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 August 10, 2016, 113 days after receiving the submission on April 19, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K161100 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2016
Decision Date August 10, 2016
Days to Decision 113 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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