Cleared Traditional

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

K180616 · Contamac, Ltd. · Ophthalmic
Apr 2018
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K180616 is an FDA 510(k) clearance for the OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon 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 April 25, 2018, 48 days after receiving the submission on March 8, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K180616 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2018
Decision Date April 25, 2018
Days to Decision 48 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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