Cleared Traditional

MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

K962006 · Menicon Co, Ltd. · Ophthalmic
Oct 1996
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K962006 is an FDA 510(k) clearance for the MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS, 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 9, 1996, 140 days after receiving the submission on May 22, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K962006 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1996
Decision Date October 09, 1996
Days to Decision 140 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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