MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution— 510(k) K253795
Substantially EquivalentMenicon Co, Ltd.
FDA 510(k) clearance K253795 for MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution, Substantially Equivalent on 2026-08-13. Applicant: Menicon Co, Ltd.. Device class: 2.
Summary
Menicon's MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is filed under product code LPN, soft lens product accessories. The record gives no other product details.
Class II, 21 CFR 886.5928. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Menicon filed from Nagoya, Japan. The decision came 258 calendar days after receipt (November 28, 2025 to August 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Menicon Co, Ltd.
- Product code
- Product code LPN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nagoya, JP
Recent devices under product code LPN
view allMore clearances from Menicon Co, Ltd.
view all- K262495 — Miru 1day UpSide (midafilcon A)
- 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 LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
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.