Miru 1day UpSide (midafilcon A)— 510(k) K262495
Substantially EquivalentMenicon Co, Ltd.
FDA 510(k) clearance K262495 for Miru 1day UpSide (midafilcon A), Substantially Equivalent on 2026-09-17. Applicant: Menicon Co, Ltd.. Device class: 2.
Summary
Menicon Co, Ltd. filed Miru 1day UpSide (midafilcon A) under product code LPL (Lenses, Soft Contact, Daily Wear). The record doesn't describe the lens beyond its name and code.
Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Menicon filed from Nagoya, Japan. The decision came 59 calendar days after FDA received it (July 20 to September 17, 2026).
Clearance details
- Applicant
- Menicon Co, Ltd.
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nagoya, JP
Recent devices under product code LPL
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- K253875 — OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens +2 more
- K262941 — Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
More clearances from Menicon Co, Ltd.
view all- K253795 — MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
- K193399 — Miru 1day UpSide (midafilcon A)
- K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
- K180819 — One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
- K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.