Cleared Traditional

MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

K103561 · Menicon Co, Ltd. · Ophthalmic
Feb 2011
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K103561 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. (Wilmington, US). The FDA issued a Cleared decision on February 3, 2011, 59 days after receiving the submission on December 6, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K103561 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2010
Decision Date February 03, 2011
Days to Decision 59 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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