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.
Clearance details
- Applicant
- Menicon Co, Ltd.
- Product code
- 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- 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
- K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
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.