Cleared Traditional

Hyper GP (tisilfocon A) Daily Wear Contact Lens

K182304 · Contamac, Ltd. · Ophthalmic
Nov 2018
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K182304 is an FDA 510(k) clearance for the Hyper GP (tisilfocon 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 November 23, 2018, 91 days after receiving the submission on August 24, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K182304 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2018
Decision Date November 23, 2018
Days to Decision 91 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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