Cleared Traditional

OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.

K070628 · Contamac, Ltd. · Ophthalmic
May 2007
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K070628 is an FDA 510(k) clearance for the OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS., 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 May 1, 2007, 55 days after receiving the submission on March 7, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K070628 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2007
Decision Date May 01, 2007
Days to Decision 55 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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