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The Tracker / September 2026 / K262495

510(k) cleared

Miru 1day UpSide (midafilcon A)

Menicon Co, Ltd. · Sep 17, 2026 · K262495

FDA cleared the Miru 1day UpSide (midafilcon A) from Menicon Co, Ltd. on Sep 17, 2026 under K262495, a traditional 510(k). The device falls under product code LPL, Lenses, Soft Contact, Daily Wear, regulated at 21 CFR 886.5925 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jul 20, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Menicon Co, Ltd. has one other decision in the tracker over the last 12 months: K253795 (MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution).

Questions & Answers

What did FDA clear under K262495?

K262495 is the FDA 510(k) for Miru 1day UpSide (midafilcon A), submitted by Menicon Co, Ltd.. FDA's decision date was Sep 17, 2026, under product code LPL (Lenses, Soft Contact, Daily Wear).

Who makes the Miru 1day UpSide (midafilcon A)?

Menicon Co, Ltd., based in Nagoya, is the applicant of record for K262495.

How long did the K262495 review take?

FDA received the submission on Jul 20, 2026 and issued its decision on Sep 17, 2026, 59 days later.

← All decisions in September 2026

Sources