Cleared Traditional

MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR

K943784 · Menicon Co, Ltd. · Ophthalmic
Oct 1994
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K943784 is an FDA 510(k) clearance for the MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Menicon Co, Ltd. (Washington, US). The FDA issued a Cleared decision on October 20, 1994, 86 days after receiving the submission on July 26, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K943784 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1994
Decision Date October 20, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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