Cleared Traditional

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

K191872 · Menicon Co, Ltd. · Ophthalmic
Mar 2020
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K191872 is an FDA 510(k) clearance for the Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on March 2, 2020, 234 days after receiving the submission on July 12, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K191872 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2019
Decision Date March 02, 2020
Days to Decision 234 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPN — Accessories, Soft Lens Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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