Cleared Traditional

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

K212631 · Contamac, Ltd. · Ophthalmic
Mar 2022
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K212631 is an FDA 510(k) clearance for the Optimum Infinite (tisilfocon A) 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 March 17, 2022, 210 days after receiving the submission on August 19, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K212631 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2021
Decision Date March 17, 2022
Days to Decision 210 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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