Cleared Traditional

OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

K033594 · Contamac, Ltd. · Ophthalmic
Mar 2004
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K033594 is an FDA 510(k) clearance for the 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 March 19, 2004, 127 days after receiving the submission on November 13, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K033594 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2003
Decision Date March 19, 2004
Days to Decision 127 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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