Cleared Traditional

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

K081178 · Contamac, Ltd. · Ophthalmic
Oct 2008
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K081178 is an FDA 510(k) clearance for the OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Contamac, Ltd. (Grand Junction, US). The FDA issued a Cleared decision on October 9, 2008, 167 days after receiving the submission on April 25, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K081178 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2008
Decision Date October 09, 2008
Days to Decision 167 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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