Cleared Traditional

Miru 1day UpSide (midafilcon A)

K193399 · Menicon Co, Ltd. · Ophthalmic
Jun 2020
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K193399 is an FDA 510(k) clearance for the Miru 1day UpSide (midafilcon A), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on June 17, 2020, 194 days after receiving the submission on December 6, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K193399 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2019
Decision Date June 17, 2020
Days to Decision 194 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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