Cleared Special

MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

K062548 · Contamac, Ltd. · Ophthalmic
Nov 2006
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K062548 is an FDA 510(k) clearance for the MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) 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 November 1, 2006, 63 days after receiving the submission on August 30, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K062548 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2006
Decision Date November 01, 2006
Days to Decision 63 days
Submission Type Special
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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